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

Lot Number 0032624200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/14/2024

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a pulse field ablation (pfa) procedure using a farawave pfa catheter the guidewire lumen detached from the tip of the catheter.The catheter was prepared and tested with no issue and was used to isolate three pulmonary veins.When advancing the catheter towards the final pulmonary vein, the right superior pulmonary vein (rspv), they could see on fluoroscopy that the guidewire was no longer through the center tip of the catheter.The catheter was withdrawn, and the physician could see that the guidewire lumen had detached from the tip of the catheter.The procedure was cancelled as the physician suspected that a section of the guidewire lumen may have detached and remains in the patient, for this reason the patient was hospitalized over night.No adverse events have been reported and a ct scan performed on the patient did not show any foreign material in the patient so they were discharged the day following the procedure.Photos of the catheter were submitted to boston scientific for review.A preliminary review of the images indicate that the guidewire lumen appeared to have remained intact but only detached from the tip of the catheter splines and retracted into the catheter sheath.The catheter is not expected to be returned as it was disposed of by the facility at the end of the procedure.

• 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: 19177607
• MDR Text Key: 341475206
• Report Number: 2124215-2024-24913
• 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: 04/24/2024

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: 0032624200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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