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

Lot Number 0032592600

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/18/2024

Event Type  malfunction  

Event Description

It was reported that a farawave catheter after ablation to treat an atrial flutter presented a issue with the guidewire.After ablation of the left superior pulmonary vein, left inferior pulmonary vein and right superior pulmonary vein, the physician tried to intubate the right inferior pulmonary vein with the guidewire, was seen that the guidewire was suddenly outside of the distal tip of the catheter, outside the catheter array (suspected guidewire lumen detachment).As troubleshooting was tried to bring it back inside the tip of the catheter but unfortunately this was not successful.To solve the issue the device was replaced, and the procedure was completed without patient complications.The device is expected to be returned.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Upon device return and inspection, it was observed that the guidewire lumen was no longer adhered to the tip of the spline cage, resulting in the inability to deploy the catheter.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.

Event Description

It was reported that a farawave catheter after ablation to treat an atrial flutter presented a issue with the guidewire.After ablation of the left superior pulmonary vein, left inferior pulmonary vein and right superior pulmonary vein, the physician tried to intubate the right inferior pulmonary vein with the guidewire, was seen that the guidewire was suddenly outside of the distal tip of the catheter, outside the catheter array (suspected guidewire lumen detachment).As troubleshooting was tried to bring it back inside the tip of the catheter but unfortunately this was not successful.To solve the issue the device was replaced, and the procedure was completed without patient complications.The device has been returned.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• 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: 19212769
• MDR Text Key: 341384146
• Report Number: 2124215-2024-25714
• 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: 04/30/2024

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: 0032592600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1