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

Lot Number 0008020818

Device Problem Defective Device (2588)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 15feb2024.It was reported that during preparation for a procedure to treat paroxysmal atrial fibrillation a farawave ablation catheter was selected for use, however, the handle of the device was found broken, therefore it was decided to replace the device, and the issue was resolved.The procedure was completed.No patient complications were reported.However, analysis of the returned device revealed that the guidewire lumen tip bond was broken.

Manufacturer Narrative

Upon device return and inspection, it was observed that the guidewire lumen was no longer adhered to the tip of the spline cage, resulting in the inability to deploy the catheter.No other abnormalities were noted on the device.The guidewire lumen was originally bonded to the tip, but failed, and is now preventing the deployment of the spline cage when the slider is pulled back.It's unknown how the bond was broken or failed.

• 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: 18797509
• MDR Text Key: 336441589
• Report Number: 2124215-2024-11775
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/28/2024

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: 0008020818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1