MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Device Problem Off-Label Use (1494)

Patient Problems Arrhythmia (1721); Heart Block (4444)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced atrioventicular (av) first degree heart block and arrhythmia.During a pulse field ablation (pfa) procedure, a farawave catheter was selected for use.The physician wanted to use the pfa catheter in the superior vena cava (svc), despite being informed that it was off label, physician still wanted to proceed with treating the svc.While treating the svc, the patient's sinoatrial (sa) node was knocked out and eventually, the patient went into junctional rhythm before going back to sinus by the time they left the room.The patient was then admitted over night with rapid ventricular response (rvr) and treated with amiodarone anti-arrhythmic medication and settled into av first degree heart block.The patient was fine, and no further action was being planned.The catheter will not be returned as it was disposed.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): CENTERPOINT SYSTEMS; west valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19164768
• MDR Text Key: 340838709
• Report Number: 2124215-2024-24508
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention