Freezor Xtra

Indications, Safety, and Warnings

Indications

The Freezor Xtra Cardiac CryoAblation Catheter is intended for use in treatment of cardiac arrhythmias.

Contraindications

The Freezor Xtra Cardiac CryoAblation Device 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

Cryoadhesion – 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.

Improper connection – Do not connect the cryoablation catheter to a radiofrequency (RF) generator or use it to deliver RF energy. Doing this may cause catheter malfunction or patient harm.

CryoMapping – The impact of CryoMapping with respect to patient outcomes has not fully been characterized.

RF ablation – Before powering up an RF generator or applying RF energy, disconnect the cryoablation catheter from the CryoConsole to avoid an error message and unnecessary catheter replacement.

Pressurized refrigerant – 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.

Post-ablation period – Closely monitor patients undergoing cardiac ablation procedures during the post-ablation period for clinical adverse events.

Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.

Fluoroscopy required for catheter placement – The use of fluoroscopy during catheter ablation procedures presents the potential for significant x-ray exposure to both patients and laboratory staff. Extensive exposure can result in acute radiation injury and increased risk for somatic and genetic effects. Only perform catheter ablation after giving adequate attention to the potential radiation exposure associated with the procedure, and taking steps to minimize this exposure. Give careful consideration before using the device in pregnant women.

Catheter positioning around the chordae tendineae – 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.

Cryoablation near prosthetic heart valves – 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.

Transaortic approach – Use adequate fluoroscopic visualization during a transaortic approach to avoid placing the ablation catheter within the coronary vasculature. Catheter placement within the coronary vasculature may cause vascular injury.

Do not resterilize – Do not resterilize this device for purpose of reuse. Resterilization may compromise the structural integrity of the device or create a risk of contamination from the device that could result in patient injury, illness, or death.

For single use only – This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.

Catheter handling –

■ Do not use excessive force to advance or withdraw the catheter, especially if resistance is encountered.

■ Use extreme care when manipulating the catheter. Lack of careful attention can result in

injury such as perforation or tamponade.

■ Do not use the catheter if it is kinked, damaged, or cannot be straightened.

■ Straighten the cooling segment before inserting or withdrawing the catheter.

■ Do not at any time preshape or bend the catheter shaft or cooling segment. Bending or kinking the catheter shaft may damage internal structures and increase the risk of catheter failure. Prebending of the distal curve can damage the catheter.

■ Catheter advancement should be performed under fluoroscopic guidance.

Biohazard disposal – Discard all used catheters and sterile components in accordance with hospital procedures.

Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the CryoConsole and catheters or patient injury or death may occur.

System compatibility – Use only Medtronic cryoablation catheters, refrigerant tanks, and components with the CryoConsole. The safety and use of other catheters or components has not been tested.

Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the sterile packaging or catheter is damaged, do not use the catheter. Contact your Medtronic representative.

Catheter integrity – Do not use the catheter if it is kinked or damaged. If the catheter becomes kinked or damaged while in the patient, remove it and use a new catheter. Prior to injecting, the physician should ensure that there is no kink in the catheter.

Required use environment – Cryoablation procedures should be performed only in a fully equipped facility.

Qualified users – This equipment should be used only by or under the supervision of physicians trained in cryoablation procedures.

Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to fluids or solvents. If these components get wet, the cryoablation system may not function properly, and connector integrity may be compromised.

Cardioversion/defibrillation during ablation procedure – Disconnect the catheter's electrical connection prior to cardioversion/defibrillation. Failure to do so may trigger system messages indicating a need for catheter exchange.

Anticoagulation therapy – Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing left-sided and transseptal cardiac procedure, and for selected patients undergoing right-sided procedures. Administer anticoagulation therapy before and after the procedure according to the hospital standards.

Environmental limits – Perform cryoablation procedures only within the environmental parameters. Operating outside these parameters may prevent the start or completion of a cryoablation procedure.

Embolism risk – 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.