Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea;  Dizziness; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache;  Hemoptysis Hypotension/hypertension; Lightheadedness; Myocardial infarction; Nausea/vomiting Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.

Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic's website at www.medtronic.com.

Caution: Federal law (USA) restricts this devices to sale by or on the order of a physician.

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Brief Statement: Arctic Front Advance Pro™ Cardiac Cryoablation Catheter

Indications

The Arctic Front Advance Pro cardiac cryoablation catheter systems are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.

Contraindications

Use of the cryoballoon is contraindicated: 1) In the ventricle because of the danger of catheter entrapment in the chordae tendineae, 2) In patients with one or more pulmonary vein stents, 3) In patients with cryoglobulinemia, 4) In patients with active systemic infections, and 5) In conditions where the manipulation of the catheter within the heart would be unsafe (e.g., intracardiac mural thrombus).

Warnings/Precautions

Do not re-sterilize this device for purpose of reuse. Use only a compatible Medtronic 12 Fr inner diameter sheath with the Arctic Front Advance Pro cryoballoon. Using another sheath may damage the catheter or balloon segment. Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inflation to avoid catheter damage. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, this may lead to tissue injury. Do not advance the balloon beyond the guidewire to reduce the risk of tissue damage. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency, or premature failure of the prosthetic valve. Always inflate the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. Esophageal ulcerations have been observed in some subjects who have undergone left atrial ablation with the Arctic Front™ family. As with other forms of left atrial ablation, the physician should consider appropriate medical strategies to minimize the risk of esophageal injury. Damage to the lung or tracheobronchial tree has been observed in some subjects who have undergone left atrial ablation with the Arctic Front family. The physician should consider appropriate medical strategies to minimize the risk of damage to the lung or tracheobronchial tree. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The Arctic Front and Arctic Front Advance cryoballoons were not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.

Potential Complications

Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Access site complications (e.g., bruising, ecchymosis); Anemia; Anxiety; Arrhythmia (e.g., atrial flutter, bradycardia, heart block, tachycardia); Back pain; Bleeding from puncture sites; Bronchial constriction; Bronchial fistula; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Coronary artery spasm; Cough; Death; Diarrhea; Dizziness; Embolism; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/Hypertension; Infection (e.g., pericarditis, sepsis, urinary); Lightheadedness; Myocardial infarction; Nausea/vomiting; Perforation; Pericardial effusion; Phrenic nerve injury; Pleural effusion; Pneumonia; Pneumothorax; Pseudoaneurysm; Pulmonary edema; Pulmonary hemorrhage; Pulmonary vein dissection; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Transient ischemic attack; Vagal nerve injury (e.g., gastroparesis); Vasovagal reaction; Visual Changes (e.g., blurred vision).

Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Brief Statement: Achieve Mapping Catheter Models 990063-015/-020

Indications

The Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only. The Achieve Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

Contraindications

The catheter is contraindicated as follows:

• For use as an ablation device

• For use with transseptal sheaths featuring side holes larger than 1.00 mm in diameter

• Retrograde approach

The catheter is contraindicated in patients with:

• An active systemic infection

• Left atrial thrombus

• Pulmonary vein stents

• Prosthetic heart valve (tissue or mechanical)

• Myxoma

• Interatrial baffle or patch

• Conditions where the manipulation of the catheter within the heart would be unsafe

• Acute myocardial infarction

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

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Brief Statement: Achieve Advance Mapping Catheter

Indications

The Achieve Advance™ Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only. The Achieve™ mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Contraindications

The catheter is contraindicated as follows:

• For use as an ablation device
• For use with transseptal sheaths featuring side holes larger than 1.00 mm (0.04 in) in diameter
• Retrograde approach

Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions:

• An active systemic infection
• Left atrial thrombus
• Pulmonary vein stents
• Prosthetic heart valve (tissue or mechanical)
• Myxoma
• Interatrial baffle or patch
• Conditions where the manipulation of the catheter within the heart would be unsafe
• Acute myocardial infarction

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Brief Statement: Freezor™ Cardiac Cryoablation Catheter

Indications

The 7 Fr Freezor Cardiac Cryoablation Catheter, CryoConsole System, and related accessories are indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

Contraindications

This device is contraindicated in patients with active systemic infection, where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus) and in patients with cryoglobulinemia.

Warnings/Precautions

The impact of cryomapping with respect to patient outcomes has not been fully characterized. The Freezor Catheter contains a pressurized refrigerant during operation. Release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism. If an unanticipated event occurs, stop the procedure at any time by pushing the RED button on the console control panel. Do not pull on the Freezor Catheter, umbilicals, or CryoAblation Console while the catheter tip is frozen to the endocardial tissue, as this could lead to cardiac or vascular damage. Do not connect the Freezor Catheter to any radiofrequency generator or use the Freezor Catheter to deliver RF ablation energy, because this could cause catheter malfunction and/or patient harm. Do not resterilize or re-use any Freezor Catheter or sterile accessory under any circumstances. Freezor Catheters and sterile accessories are designed for single use only. Do not attempt to operate the 7 Fr Freezor Cardiac CryoAblation Catheter prior to reading and understanding the Instructions for Use.

Potential Complications

Potential complications that may be associated with cardiac catheterization and ablation listed alphabetically below include, but are not limited to: Access site complications including pain, hematoma, ecchymosis, infection, thrombosis or AV fistula; arrhythmias include new arrhythmias and/or worsening of existing arrhythmias; cardiac arrest and/or death; cardiac perforation with hemopericardium and/or tamponade; catheter entrapment in cardiac structures requiring surgical intervention; chest pain; coronary artery spasm/dissection/thrombosis; endocarditis; exposure to x-ray energy with possible cancer risk or harm to fetus; gas embolism with possible tissue infarction; heart block, partial or complete, potentially requiring implantation of a permanent pacemaker; hemorrhage; hemothorax; myocardial infarction; pericardial effusion; pericarditis or pericardial effusion; pleural effusion; pneumothorax; pseudoaneurysm; pulmonary edema; pulmonary embolism; stroke; thrombus, intravascular or intracardiac; thromboembolism with potential tissue infarction; transient ischemic attack; valvular damage; vasovagal reaction.

See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brief Statement: Freezor™ Xtra Cardiac Cryoablation Catheter

Indications

The Freezor Xtra Cardiac Cryoablation Catheter, CryoConsole system, and related accessories are indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT). The Freezor Xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Freezor Xtra catheter freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryonecrosis.

Contraindications

The Freezor Xtra Cardiac Cryoablation Catheter is contraindicated in patients with the following conditions:

• Active systemic infections
• Cryoglobulinemia
• Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus).

Warnings/Precautions

The catheter contains pressurized refrigerant during operation. Release of this gas into the body or circulatory system due to equipment failure or misuse could result in gas embolism, pericardial tamponade, tissue emphysema, or other patient injury. Do not pull on the Freezor Xtra catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury. Do not connect the Freezor Xtra catheter to a radiofrequency (RF) generator or use it to deliver RF ablation energy. Doing this may cause catheter malfunction or patient harm. Do not resterilize this catheter for purpose of reuse. This catheter is intended only to be used once for a single patient. Cryoablation involving coronary vessels with liquid nitrous oxide systems has been associated with subsequent clinically significant arterial stenosis. Care should be taken to minimize unnecessary contact with coronary vessels during cryoablation. Avoid positioning the catheter around the chordae tendineae, as this increases the likelihood of catheter entrapment within the heart, which may necessitate surgical intervention or repair of injured tissues. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue). The catheter may become trapped in the valve, damaging the valve and causing valvular insufficiency or premature failure of the prosthetic valve. Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing endocardial right-sided procedures. Administer anticoagulation therapy before and after the procedure according to the hospital standards. Introducing any catheter into the circulatory system entails the risk of air or gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Cryoablation procedures should be performed only in a fully equipped facility. This equipment should be used only by or under the supervision of physicians trained in surgical or endocardial cryoablation procedures. Do not attempt to operate the Freezor Xtra catheter prior to reading and understanding the Instructions for Use.

Potential Complications

Potential complications/adverse events associated with cardiac catheter cryoablation procedures include, but are not limited to, the following conditions: Access site complications (e.g., hematoma, infection, thrombosis, ecchymosis, AV fistula, bleeding from puncture site, hemorrhage), Arrhythmia (including new or worsening existing arrhythmias), Cardiac arrest, Cardiac tamponade/perforation, Catheter entrapment in cardiac structures requiring surgical intervention, Chest discomfort, pain or pressure, Coronary artery spasm, dissection, thrombosis, Damage to adjacent organs/structures, Death, Endocarditis, Heart block, partial or complete, potentially requiring permanent pacemaker, Hematoma, Hemothorax, Infection/sepsis, Myocardial infarction, Pericardial effusion, Pericarditis, Pleural effusion, Pneumothorax, Pseudoaneurysm, Pulmonary edema, Pulmonary embolism, Stroke/transient ischemic attack/embolism, Thrombosis, Valvular damage, Vascular complication (e.g., stenosis), Vasovagal reaction.

See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Brief Statement: Freezor^™ Max

Indications

The Freezor^™ MAX Cardiac CryoAblation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal atrial fibrillation in conjunction with the Arctic Front^™ Cardiac CryoAblation Catheter for the following uses: 1) Gap cryoablation to complete electrical isolation of the pulmonary veins 2) Cryoablation of focal trigger sites and 3) Creation of ablation line between the inferior vena cava and the tricuspid valve.

Contraindications

Use of Freezor^™ MAX cryocatheter is contraindicated in patients with active systemic infections, in patients with cryoglobulinemia and other conditions where the manipulation of the catheter would be unsafe (For example, intracardiac mural thrombus).

Warnings/Precautions

Do not re-sterilize this device for purpose of reuse. Do not connect the cryocatheter to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. Disconnect the catheter's electrical connection prior to defibrillation. The catheter contains pressurized refrigerant during operation, release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency or premature failure of the prosthetic valve. Use adequate fluoroscopic visualization during a transaortic approach to avoid placing the ablation catheter within the coronary vasculature. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. The Freezor MAX catheter was not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.

Potential Complications

Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage; Fatigue; Fever; Headache; Hemoptysis Hypotension/hypertension; Lightheadedness; Myocardial infarction; Nausea/vomiting Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.

Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

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Brief Statement: FlexCath Advance™ Steerable Sheath

Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Brief Statement: CryoConsole

Indications

Medtronic CryoCath Cryoablation system is comprised of cryoablation catheters and a CryoConsole. The Arctic Front^™ Cardiac CryoAblation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The Freezor^™MAX Cardiac CryoAblation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal atrial fibrillation in conjunction with the Arctic Front Cryoballoon. Please read the specific product labeling indications for use before using the CryoAblation system.

Contraindications

Use of Arctic Front cryoballoon is contraindicated as follows:

• In the ventricle because of the danger of catheter entrapment in the chordae tendinae.
• In patients with active systemic infections.
• In conditions where the manipulation of the catheter within the heart would be unsafe (e.g. intracardiac mural thrombus).
• In patients with cryoglobulinemia.
• In patients with one or more pulmonary vein stents.

Use of Freezor MAX cryocatheter is contraindicated in patients with the following conditions:

• Active systemic infections
• Cryoglobulinemia
• Other conditions where the manipulation of the catheter would be unsafe (For example, intracardiac mural thrombus)

Warnings/Precautions

Do not re-sterilize the cryoablation catheters for purpose of reuse. Use only the appropriate size of the FlexCath® Steerable Sheath with the cryoablation catheters because using another sheath may damage the catheter or balloon segment. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis. Do not connect the cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation, release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency or premature failure of the prosthetic valve. Always inflate the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. Placing a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture, to avoid nerve injury. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The cryoablation (Arctic Front and Freezor MAX) catheters were not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.

Potential Complications

Potential complications/ adverse events that may be associated with cardiac catheterization and ablation listed alphabetically below include but are not limited to: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage; Fatigue; Fever; Headache; Hemoptysis Hypotension/hypertension; Lightheadedness; Myocardial infarction; Nausea/vomiting Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.

Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Brief Statement: Radiofrequency (RF) Ablation Catheters

• RF Marinr™ Multi-Curve (MC) Steerable Catheter
• 5Fr RF Marinr™ Steerable Catheter
• RF Contactr Dual-Curve Catheters
• RF Enhancr Single-Curve Catheters
• RF Conductr™ Multi-Curve (MC) Bi-Directional Catheters

Indications

RF catheters are indicated for use with the Medtronic RF generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications

The use of this device is contraindicated in patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings/Precautions

Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter Instructions for Use. Use the catheter with only a Medtronic RF generator, accessories, and cables. The safety and use with other RF generators or accessories has not been tested. Use only isolated amplifiers, pacing equipment, and ECG equipment or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps. The catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters, and experienced in performing RF catheter ablation procedures. Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.

Potential Complications

Potential complications include, but are not limited to, pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; partial or complete AV block; and death. Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. Catheters with distal pair electrode spacing greater than two mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block. Implanted devices such as pacemakers and implantable cardioverter-defibrillators (ICDs) may be adversely affected by RF energy. Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Brief Statement: Soloist Quadrapolar Fixed-Curve Catheters

Intended Use

The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications

There are no known contraindications for this catheter.

Warnings

• This device is for single use only. Do not resterilize and/or reuse. Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
• This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be "front end" isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Do not use in the coronary vasculature other than in the coronary sinus.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brief Statement: Stablemapr SM Duodecapolar Steerable Catheter

Indications for Use

The Medtronic StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications

There are no known contraindications for this catheter.

Warnings

This device is for single use only. Do not resterilize and reuse the catheter. This may result in loss of proper electrical and mechanical function.

• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end isolated”, or have an isolated patient cable (IEC 601-1 Type CF equipment or equivalent). Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection and death.
• Use only connecting cables supplied by Medtronic or patient injury, operator injury, or equipment damage may occur.
• Do not allow moisture into connectors of the StableMapr catheter or connecting cables. If the connectors get wet, the system may not function correctly.
• The safety and effectiveness of this device as an ablation catheter have not been established. Therefore, such use is considered investigational.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brief Statement: Torqr Catheters

• Torqr 5 Fr/Torqr 6 Fr Quadripolar Fixed-Curve Catheters
• Torqr CS Fixed-Curve Decapolar Catheter

Intended Use

The Medtronic Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications

There are no known contraindications for this catheter.

Warnings

• This device is for single use only. Do not resterilize and/or reuse.
• Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
• This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end” isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION. PRECAUTIONS
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brief Statement: Marinr Catheters

• Marinr CS Steerable Decapolar Catheter
• Marinr MC and MCXL Steerable Catheters
• Marinr SC Steerable Quadrapolar Catheter

Indications for Use

The Medtronic Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications

There are no known contraindications for these catheters.

Warnings/Precautions

• This device is for single use only. Do not resterilize and reuse the catheter. This may result in loss of proper electrical and mechanical function.
• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end isolated”, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection, and death.
• Use only connecting cables supplied by Medtronic or patient injury, operator injury, or equipment damage may occur.
• Do not allow moisture into connectors of the Marinr Catheter or connecting cables. If the connectors get wet, the system may not function correctly.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION.
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Brief Statement: Brockengrough Curved Needles

The Medtronic Brockenbrough™ curved needle is made up of an outer cannula and an inner stylet. The outer cannula is made of flexible thin-walled tubing. The inner stylet is solid, much stiffer and closely fitting, whose sharpened end protrudes 2-3 mm beyond the tip of the cannula.

Indications for Use

The Brockenbrough curved needle is used in conjunction with transseptal catheters to puncture the atrial septum to allow conducting a left heart catheterization procedure through the right atrium. The Brockenbrough curved needle is intended for single use only.

Contraindications

The use of the Brockenbrough curved needle is contraindicated in patients with the following conditions:

• Distorted anatomy due to congenital heart disease
• Significant chest or spine deformity
• The inability to lie flat
• Ongoing anticoagulation
• Marked atrial enlargement
• Left atrial thrombus or tumor
• Dilated aortic root
• Previous patch repair of the interatrial septum

Warnings and Precautions 

• The Brockenbrough curved needle is designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this needle should be restricted to those specialists trained to perform transseptal procedures to minimize the complications associated with this procedure.
• The Brockenbrough curved needle must be sharp to minimize the risk of puncturing the left atrial wall just after crossing the septum.
• Use continuous pressure monitoring and repeated biplane fluoroscopy of the tip during any positioning, to minimize the risk of advancing the Brockenbrough curved needle into an undesired location and the subsequent bleeding that might occur.
• Extreme caution should be used in patients with a small left atrium, to avoid puncture of the left atrial wall.
• Never advance the Brockenbrough curved needle until the catheter is correctly positioned on the atrial septum to minimize the risk of advancing the needle into an undesired location.
• Never advance a dilator, sheath or catheter until the Brockenbrough curved needle has clearly entered the left atrial cavity, as confirmed by a distinct left atrial pressure record and the tip of the needle is in the left atrium on fluoroscopy.
• If a dilator, sheath or catheter are inadvertently advanced into the pericardial space, do not remove them until the patient is in surgery.
• Do not reuse the Brockenbrough curved needle. The Brockenbrough curved needle must be discarded after one procedure. Its structural integrity and/or function can be impaired through reuse or cleaning. All parts are extremely difficult to clean after being exposed to biological materials, and adverse patient reactions can result from reuse.
• The Brockenbrough curved needle has been gamma sterilized prior to shipment. Carefully inspect the package before opening. Damaged packages should be returned to Medtronic. The Brockenbrough curved needle cannot be resterilized.
• Do not use the product after its expiration date.
• At no time should the introducer or guide wire be advanced or withdrawn when resistance is met without first determining the cause by fluoroscopy and taking remedial action.
• Ensure that the catheter is appropriate for the Brockenbrough curved needle being used.
• After use, the Brockenbrough curved needle may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brief Statement: Mullins Transseptal Introducer Sheath

The Medtronic Transseptal Catheter Introducer Sheaths are available in two designs:

Mullins Transseptal  Catheters Product Description

Mullins Transseptal Catheter Introducer Set The Mullins transseptal catheter introducer set consists of a long radiopaque sheath and dilator. The distal section is curved to accommodate the curved Brockenbrough™ needle and to enable positioning against the atrial septum

Medtronic Transseptal Catheters Product Description 

Medtronic Transseptal Catheter Introducer Set is the same as the Mullins Transseptal Catheter Introducer Set except that the Medtronic transseptal introducer sheath contains a gasket seal assembly within the hub to minimize blood loss during catheter introduction or exchange, and a sideport for fluid infusion, blood sampling, or pressure monitoring.  In addition, the sideport has a three-way stopcock attached.  

Contraindications

The introducer sets are contraindicated for use under these conditions:

• Known or suspected left atrial myxoma
• Previous systemic embolization from left side of the heart
• Previous intra-atrial septal pouch

Warnings

• Do not advance the dilator or sheath through the interatrial septum without first observing an acceptable left atrial pressure tracing. Advancing the dilator or sheath too quickly could cause placement in an undesired location or subsequent bleeding.
• Use repeated biplane fluoroscopy of the tip during any positioning to prevent advancing the device into an undesired location and the subsequent bleeding that might occur.
• Maintain continuous pressure monitoring and repeated anterior-posterior and lateral visualization under fluoroscopy throughout the procedure.
• Withdraw each component slowly to help prevent a vacuum in the sheath. Do not apply suction directly to the sheath. If blood does not flow freely from the sheath, it suggests that the distal end opening is against the wall of the atrium or against a pulmonary vein. Withdraw the sheath approximately 1 finger width until flow is reestablished.
• This device is for single use. Reuse of this device creates a potential risk of patient or user infections due to contamination. Contamination of the device may lead to injury, illness or death of the patient. Reuse, Reprocessing, resterilization may compromise the structural integrity of the device.
• The Medtronic and Mullins transseptal catheter introducer sets are designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this device should be restricted to those specialists trained to perform transseptal procedures.
• Aspiration is recommended when withdrawing the catheter or dilator to remove any fibrin deposition that may have accumulated in or on the tip of the sheath. Aspiration helps prevent embolization of the fibrin and the subsequent ischemia that might occur.
• Perform frequent aspirations and saline flushing of the sheath, dilator, and catheter to help minimize the potential for air emboli.
• For Medtronic Transseptal Set Only: It is essential to aspirate all air from the infusion sideport before infusion through the side port or the introduction of a catheter. Aspiration helps prevent an air embolus and the subsequent ischemia that might occur.
• For Medtronic Transseptal Set Only: A continuous drip under pressure is required through the sideport when the introducer is left in the vessel.

Brief Statement: CardioInsight™ Noninvasive 3D Mapping System

Indications and relevant warnings and instructions for use can be found in the product labeling supplied with each device.

Caution: Federal law (USA) restricts these devices for sale by or on the order of a physician. This system is intended for use only by persons trained and/or under the guidance of Medtronic personnel (such as Field Clinical Engineers) as referenced in the system user manuals.