MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0008021756

Device Problem Off-Label Use (1494)

Patient Problems Presyncope (4410); Heart Block (4444)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the patient experienced complete heart block (chb).This procedure consisted only of posterior wall ablations which are considered off-label use for the farawave catheter.The farawave's instructions for use (ifu) sates that "the farawave catheter is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation".After one application temporary complete heart block was observed for approximately 10 to 15 seconds.No interventions took place at that time and the procedure was completed successfully.After the procedure, prior to discharge, more episodes of chb were identified.The patient was admitted to the hospital for observation and the patient "remained in 2:1 hearth block for several days post procedure" and also experienced brief episodes of ventricular standstill, during which the patient became presyncopal.An infusion of isoprenaline was administered throughout the hospitalization to stabilize their rhythm and the patient was discharged on the fourth day, once they were confirmed to stay in sinus rhythm without the infusion.The catheter is not expected to be returned for analysis as it was disposed of by the site.

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, 31MM
• 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): AGILE MV INC; 3700 st patrick st suite 102; montreal, qc H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19038776
• MDR Text Key: 339319978
• Report Number: 2124215-2024-20459
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Lot Number: 0008021756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization