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

Lot Number 0032365566

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/05/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced tissue damage due to difficulty withdrawing the catheter.During a pulse field ablation (pfa) catheter using a farawave pulsed field ablation catheter the patient experienced tissue damage due to difficulty withdrawing the catheter.After ablating and checking the right inferior pulmonary vein (ripv) a malfunction with the deployment slider on the catheter handle occurred and it was not possible to undeploy the catheter and fold the array.It was difficult to withdraw the catheter through the sheath and out of the patient, though eventually the array could be folded using a rotating motion to get it inside the sheath and allow the catheter to be withdrawn.This caused expansion of the transseptal puncture hole and the access site hole in the femoral vein.It was also observed that the catheter array had separated partially from the shaft of the catheter.The procedure was completed since the catheter could be deployed to the basket and flower shapes to ablate the final pulmonary vein, the right superior pulmonary vein (rspv), and the patient was admitted to the hospital for monitoring.The patient stayed at the hospital for two days and was discharged with no further complications observed.The device is expected to be returned for analysis.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19177609
• MDR Text Key: 341000841
• Report Number: 2124215-2024-24769
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/24/2024

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0032365566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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): Hospitalization