Indications, safety, and warnings
Affera™ Mapping and Ablation System
Indications
The Sphere-9™ catheter is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year) and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera mapping system.
The Affera Mapping System is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system’s display screen.
Contraindications
Do not use this device under the following circumstances:
- In patients with an active systemic infection.
- In patients who have had cardiac surgery in the preceding eight weeks, as the risk of perforation may increase.
- In patients with intracardiac thrombus or myxoma, as the catheter may precipitate an embolus.
- In coronary vessels with diameter smaller than the expandable ablation electrode, as the catheter may damage the coronary vessels.
- In patients with prosthetic valves, as the catheter may damage the prosthesis.
- Using the transaortic retrograde approach in patients who have had aortic valve replacement.
- Using the transseptal approach in patients with an interatrial baffle or patch, as the opening could persist and result in an iatrogenic atrial shunt.
Warnings and Precautions
Do not reuse, reprocess, or resterilize devices labeled single-use only. Only use with compatible devices listed in the IFU. The Affera Mapping System requires use of a disposable Location Reference Patch Kit to detect patient displacement and respiratory motion.
Treatment location should be confirmed using alternative techniques (e.g. fluoroscopy, intracardiac electrograms, intracardiac echocardiography) before treatment.
A connection to a compatible cardiac stimulator is allowed provided the stimulator is electrically isolated or physically disconnected when RF or PF energy is applied to the patient, outputs of the generator and stimulator must be isolated to prevent patient injury or damage to equipment.
The pacing functionality in the Affera Mapping System is not a life support device and is for diagnostic purposes only. Pacing may induce intentional or unintentional life-threatening cardiac arrhythmias.
Intravenous heparin must be used to reduce the likelihood of thromboemboli developing during the procedure. Patient injury may result from excessive delivery of fluids. Anticoagulation treatment should adhere to consensus guidelines,
Avoid steering the Sphere-9 catheter near other catheters to reduce the possibility of the catheters becoming entangled. Cardiac devices may be damaged by energy delivery. Catheter interactions with implantable leads may result in lead dislodgement or possible thrombus.
Cardiac ablation may induce intentional or unintentional life-threatening cardiac arrhythmias.
Care should be taken when ablating near sensitive structures (i.e., conduction system, coronary arteries) as unintended patient harm may occur. Catheter entrapment within the heart is a possible complication of cardiac ablation procedures that could necessitate surgical intervention.
The Affera Mapping and Ablation System has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. System operation may be temporarily interrupted if exposed to excessive external electromagnetic disturbance or ESD.
Potential Adverse Events or Potential Complications
Atrioesophageal fistula • Cardiac perforation/tamponade • Cardiac or respiratory arrest • Stroke Conduction system injury • Coronary artery spasm/occlusion/stenosis • Damage/dislodgement to ICD or implantable pacemaker • Death • Embolism • Hemoptysis • Infection • Myocardial infarction • Phrenic nerve palsy/paralysis • Pulmonary edema • Pulmonary vein stenosis • Valve damage • Vessel dissection
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 these devices to sale by or on the order of a physician.
Indications, safety, and warnings
PulseSelect™ Pulsed Field Ablation (PFA) System Brief Statement
Indications (or Intended Use)
The PulseSelect™ Pulsed Field Ablation (PFA) System is indicated for use in cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (episode duration less than 1 year).
Contraindications
The PulseSelect PFA loop catheter is contraindicated for use in patients with the following conditions:
- Active systemic infections
- A known sensitivity to Heparin
- Blood clotting abnormalities
The catheter is also contraindicated in conditions where the manipulation of the catheter within the heart would be unsafe, such as intracardiac mural thrombus.
The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.
Warnings and Precautions
To reduce the possibility of hazards associated with use of the PulseSelect PFA loop catheter:
• Use the catheter only in the recommended anatomical location. • Maintain the catheter position during the ablation. •Do not deliver energy near permanently implanted metallic objects • If coughing occurs, reposition the catheter more proximally and review sedation management. • Ensure electrodes are not in contact with any metal during ablations (for example the guide wire). • Maintain substantially circular array to ensure uniform field distribution. • If the electrode array is deployed to deliver ablation energy, avoid continuing to move the slide control forward to prevent the guide wire lumen from coming too close to the electrode array.
It is recommended that the array be captured while it is submerged to help reduce the possibility of air becoming entrapped around the electrode array during capture and catheter insertion.
Catheter integrity – Use care to avoid damage to the catheter. • Do not bend or kink the leading end of the catheter. Doing so could cause damage to the catheter lumen and make it unusable.
• Monitor the catheter throughout the procedure. If a flash is observed in the luer, replace the catheter immediately.
Electrode-electrode contact – Avoid contact between electrodes. Contact between electrodes may create a short circuit.
Embolism risk – Introducing any catheter or sheath into the circulatory system entails the risk of air, gas, or thromboembolism, which can occlude vessels and lead to tissue infarction with serious consequences. • Avoid unnecessary catheter exchanges to minimize sheath-related embolic events. • Always advance and withdraw components slowly to minimize the vacuum created and the risk of air embolism. • Aspirate and flush the sheath frequently to help minimize the potential for embolic events resulting from the introduction of air or clot formation within the sheath.
Fluoroscopy use during catheter placement – 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.
For single use only – The PFA catheter is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize the PFA catheter.
Careful manipulation of the catheter is necessary to avoid cardiac damage, perforation, or tamponade. • Do not use excessive force to advance, withdraw, or rotate the catheter, especially if resistance is encountered. Excessive force may lead to catheter damage and blood loss. • Use imaging guidance during catheter advancement, manipulation, and placement. • Vascular perforation is an inherent risk of catheter placement. • Performing ablation with the PFA catheter array inside the sheath may result in damage to the array or the sheath and should be avoided. • Performing steering manipulation with the PFA catheter array inside the sheath may result in damage to the catheter steering mechanism or the sheath and should be avoided. • The PFA generator is capable of delivering significant energy. Do not touch the ablation electrodes of the PFA catheter while operating the generator. • If the system is to be tested outside of the body, the electrode array must be immersed in saline solution in a plastic container. Never test PFA delivery in direct contact with skin.
Use of imaging during catheter manipulation and placement is strongly advised. Manipulating the catheter without imaging may result in damage to cardiac and vascular structures.
Other devices, wires, or catheters – Avoid catheter entanglement with other devices, wires, or catheters, for example, intracardiac echo catheters. Failure to do so may increase the risk of entrapment of the array or damage to the array, which may affect retrieval of the device into the transseptal sheath.
Phrenic nerve injury – To reduce the potential for phrenic nerve injury, assess for proximity of the ablation catheter to the nerve using an appropriate technique such as pacing for local phrenic nerve capture or using the test pulse feature before ablation. Stop ablation immediately if phrenic nerve impairment is observed and assess for injury.
Sheath and guide wire required – Do not attempt to advance or withdraw the catheter through the vasculature without the use of a sheath and guide wire, as it may result in damage to cardiac and vascular structures.
Implanted devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), may be adversely affected by PFA energy. • Keep external sources of pacing and defibrillation available during ablation. • Program pacemaker sensing parameters to asynchronous pacing to ensure that PFA energy is not sensed as an intrinsic event. • Deactivate ICD detection during the delivery of PFA energy. • Perform complete implantable device testing before and after ablation. • Monitor surface and intracardiac electrograms or vital signs during PFA energy delivery to assess for device interaction. Take appropriate action if any interaction is detected. • Refer to the appropriate implantable device technical manual for additional information.
Electrical safety requirements – The PFA generator meets the requirements of IEC 60601-1. It is the user’s responsibility after installation to verify and ensure that the generator meets the applicable local electrical safety requirements.
Electric shock – To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.
Electromagnetic interference (EMI) radiated – The generator emits energy during ablation at a frequency level that may cause EMI with unshielded electronic equipment. To minimize EMI, the generator should be moved away from any other electronic device. If EMI is apparent during the application of energy, EMI may be reduced by repositioning the generator or other equipment.
Electromagnetic interference (EMI) susceptibility – The generator has been designed to minimize electromagnetic interference (EMI). If interference should occur, move the generator away from the device generating the interference or place the generator at a different angle.
Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type CF equipment, or equivalent) with the PFA system and catheters or patient injury or death may occur.
Potential Adverse Events or Potential Complications
Potential adverse events associated with cardiac catheter ablation procedures include, but are not limited to, the following conditions: • Access site complications (such as, bruising, ecchymosis, arteriovenous fistula, hematoma, pseudoaneurysm) • Anemia • Arrhythmias, proarrhythmia (such as, atrial flutter, bradycardia, heart block, tachycardia) • Bleeding, possibly requiring transfusion • Bruising • Cardiopulmonary arrest • Perforation of the heart or other organs during transseptal puncture or other procedures • Cardiac tamponade • Catheter entrapment in cardiac structures requiring intervention • Cerebrovascular accident [such as stroke, transient ischemic attack (TIA)] • Chest discomfort, pain, or pressure • Collateral damage to the conduction system or coronary vasculature • Cough • Death • Embolism • Esophageal damage (including atrial esophageal fistula) • Hemoptysis • Hypotension • Hypertension • Infections (such as, sepsis) • Myocardial infarction or ischemia • Nerve injury or nerve damage (for example phrenic nerve injury) • Pericarditis or endocarditis • Pericardial effusion • Pneumothorax • Pulmonary edema • Pulmonary vein dissection • Pulmonary vein stenosis • Radiation injury or damage and late malignancy • Skin laceration or puncture • Sore throat • Unintended complete or incomplete atrioventricular node (AV-Node) or sinus node block or damage • Valvular insufficiency or damage.
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 these devices to sale by or on the order of a physician.
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