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

Lot Number 0008021443

Device Problems Difficult to Flush (1251); Material Integrity Problem (2978)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 13feb2024.It was reported that durring preperation of the farawave pulsed field ablation catheter it was impossible to flush the irrigation port whether the physician used a screwable syringe or not, he then tried to connect the irrigation, nothing came out at the other end of the catheter.When trying to deploy the catheter in basket / flower shape, he noticed that the handled seemed broken, having to apply a high amount of force to change configuration.Decision was made to change the catheter, it wasn't introduced into the patient's body.The catheter was received for analysis at boston scientific's post market laboratory where it was found the irrigation tubing had completely separated from the catheter.

Manufacturer Narrative

Upon device return and inspection, it was observed that the catheter was returned with the slider switch deployed to basket, while the spline cage remained undeployed.Additionally, it was noted that the flush port was detached from the catheter.The device was put on the x-ray to look for any possible cause for a deployment issue.A break was noticed in the guidewire lumen due to the guidewire lumen damage; deployment of the device was not possible.Additionally, the detachment of the flush port resulted in the inability to flush through the irrigation line.The catheter was dissected to further inspect the damage to the guidewire lumen and to look for any other abnormalities that could contribute to a deployment or flushing issue.Dissection of the handle confirmed the guidewire lumen damage just distal of the hypotubes.No further damage or deformation was noted on the flush lumen.Based on the available information, boston scientific's investigation findings were unable to establish a clear conclusion about the cause of the reported event.Upon device return it was noted that the flush port was detached from the device.It is unclear how the damage to the luer occurred.

• 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: 18778952
• MDR Text Key: 336405775
• Report Number: 2124215-2024-11190
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/26/2024

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: 0008021443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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