MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 35MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0008021480

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected and examined via x-ray, no abnormalities were observed at that time.Next, they inserted a guidewire through the lumen and attempted to deploy the catheter.The array was unable to deploy to any configuration and moving the slider switch had no impact on the catheter.When inspected at this point it was observed that the guidewire lumen was detached from the tip of the array.The catheter was then dissected and no abnormalities that could have led to or contributed to the guidewire lumen detachment were found.Based on all the available information boston scientific confirmed the allegation of a failure to deploy the array.The cause was determined to be component failure as the bond between the guidewire lumen and the catheter tip failed.The failure of this bond would also be the cause of the catheter's inability to deploy the array.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the catheter lost the ability to deploy during use.During preparation the catheter was tested and found to be functional.While working the right inferior pulmonary vein (ripv) 4 energizations occurred in basket and the catheter was then undeployed.When the physician then attempted to deploy to flower the catheter did not deploy, it was stated the slider switch did not work.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter was received for analysis where investigators found the guidewire lumen had become detached from the tip of the array.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 35MM
• 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: 18932829
• MDR Text Key: 338023284
• Report Number: 2124215-2024-16361
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/19/2024

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: 0008021480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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