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

Lot Number 0032535573

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/23/2024

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.When anchoring the catheter in the first pulmonary vein resistance was felt when moving the guidewire back and forth in the catheter, especially when attempting to withdraw the guidewire.The catheter was able to move freely and the guidewire could be spun while it was inside the catheter.The catheter and wire were withdrawn into the sheath and removed from the patient.Upon closer inspection, it was found that the tip of the catheter was broken and prevented the guidewire from moving.This damage was not seen when the catheter was tested before insertion.Tissue was also present at the tip of the catheter after it was withdrawn.The catheter and guidewire were replaced and the procedure was completed.No patient complications were reported.The device is expected to be returned for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.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and no abnormalities were observed.The catheter was returned, and a known good guidewire was then inserted through the catheter successfully.Functional testing was performed, and the guidewire was able to be advanced and withdrawn through the catheter with no issue.The catheters array was also able to be deployed and undeployed with no resistance.Additionally, there was no tissue or foreign matter found on or in the catheter tip or in the sterile pouch.

Event Description

It was reported that during a procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.When anchoring the catheter in the first pulmonary vein resistance was felt when moving the guidewire back and forth in the catheter, especially when attempting to withdraw the guidewire.The catheter was able to move freely, and the guidewire could be spun while it was inside the catheter.The catheter and wire were withdrawn into the sheath and removed from the patient.Upon closer inspection, it was found that the tip of the catheter was broken and prevented the guidewire from moving.This damage was not seen when the catheter was tested before insertion.Tissue was also present at the tip of the catheter after it was withdrawn.The catheter and guidewire were replaced, and the procedure was completed.No patient complications were reported.The device was received 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): 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: 19213100
• MDR Text Key: 341487392
• Report Number: 2124215-2024-26071
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 07/29/2024

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: 0032535573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 07/11/2024
• Supplement Dates FDA Received: 07/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1