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

Lot Number 0008021415

Device Problem Positioning Failure (1158)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Upon device return and inspection, it was observed that the catheter was returned with the slider switch deployed, while the spline cage remained undeployed.Additionally, it was noted that the guidewire lumen was no longer adhered to the tip of the spline cage.Due to the delamination of the guidewire lumen from the tip of the spline cage, deployment of the catheter was not possible.The device was dissected to look for any abnormalities that could have contributed to the delamination of the guidewire lumen.Nothing out of the ordinary was noted.The reported event was confirmed.

Event Description

Reportable based on analysis completed on 22feb2024.It was reported that a farawave ablation catheter during preparation, when flushing of the device was done, and the physician was bending the catheter's petals backwards in flower position, the farawave wire broke and then returned to stick position.After trying to deploy to basket and flower the slider was loose and could not be deployed back into any shape.No issues flushing the catheter.A non-boston scientific 0.035 was used.No issues during preparation.To solve the issue the device was replaced, and the procedure was completed without patient complications.The device has been returned.However, analysis of the returned device revealed the guidewire lumen detached from the tip of the spline cage.

• 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: 18827924
• MDR Text Key: 336799600
• Report Number: 2124215-2024-12883
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

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: 0008021415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/04/2024
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1