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

Lot Number 0008021535

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that during a pulse field ablation (pfa) procedure to treat atrial fibrillation (af), a farawave ablation catheter 31mm was selected for use.Imaging used included x-ray and computed tomography (ct).The left side veins were treated, however there were several attempts at locating the left veins.Upon moving to the right, the non-boston scientific guidewire became harder to move and eventually could no longer advance.The catheter was removed, and tissue was evident on the guidewire entrapped in catheter tip.The catheter and guidewire were replaced, and the procedure was completed without patient complications.The device has been returned to boston scientific for analysis.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Upon device return and inspection, it was noted that the catheter was returned with a guidewire still inserted.Some tissue was visibly stuck between the guidewire and the guidewire lumen at the tip of the spline cage, preventing the movement of the guidewire.Deployment of the device was functional.The complaint was confirmed through analysis.

Event Description

It was reported that during a pulse field ablation (pfa) procedure to treat atrial fibrillation (af), a farawave ablation catheter 31mm was selected for use.Imaging used included x-ray and computed tomography (ct).The left side veins were treated, however there were several attempts at locating the left veins.Upon moving to the right, the non-boston scientific guidewire became harder to move and eventually could no longer advance.The catheter was removed, and tissue was evident on the guidewire entrapped in catheter tip.The catheter and guidewire were replaced, and the procedure was completed without patient complications.The device has been returned to boston scientific for analysis.

• 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: 18996366
• MDR Text Key: 338989211
• Report Number: 2124215-2024-18588
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0008021535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1