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

Lot Number 0008021359

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Farawave pulsed field ablation catheter was evaluated by boston scientific.Visual inspection noted that no outer abnormalities were observed.Functional testing found that it was possible to move the guidewire back and forth.Deployment test was made and the device had failed to reach to flower mode.Dissection of the device found some adhesive residues on the flush lumen.It was also noticed that the flush lumen was heavily kinked.The "manufacturing deficiency" code was selected as most probable cause for the "difficult to deploy" allegation.The "no problem detected" was selected as most probable cause for "guidewire stuck" allegations.

Event Description

It was reported that during a pulsed field ablation electroporation procedure a farawave ablation catheter was selected for use.While inside the patient, the physician could not deploy the catheter into the flower position.The catheter got stuck in basket mode and the guidewire was stuck inside the catheter.The catheter was retracted inside the sheath.The procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.

• 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: 18803143
• MDR Text Key: 336547176
• Report Number: 2124215-2024-11722
• 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: 0008021359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1