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

Lot Number 0008021713

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 01/23/2024

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.Some minimal kinking of the flush lumen was noted.The reported event was confirmed.

Event Description

Reportable based on analysis completed on 01mar2024 it was reported that during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation (a fib) the farawave ablation catheter 31mm was selected for use, when ablating the right superior pulmonary vein (rspv) as last vein it was impossible to deploy the catheter into flower position.The troubleshooting was performed and the catheter was replaced.The procedure was completed successfully.No patient complications were reported.The device is expected to be returned.However, analysis of the retuned device revealed that the catheter tip bond failed.

• 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: 18839810
• MDR Text Key: 336959243
• Report Number: 2124215-2024-13465
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/05/2024

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: 0008021713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1