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

Lot Number 1-21C-0086

Device Problem Defective Device (2588)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

This event is being reported for aborted/cancelled procedure with a patient under sedation.During an ablation procedure a farastar ablation generator was selected for use and errors 303 and 201 occurred.After successful isolation of two veins, multiple 303 errors occurred.The connection cable and catheter were replaced, but the issue persisted.The console was restarted and error 201 was observed.As the issue persisted without resolution, the procedure was postponed.There were no patient complications.The device is expected to be returned for analysis.

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.

• Brand Name: FARASTAR PULSED FIELD ABLATION GENERATOR
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): FARAPULSE; 3715 haven avenue suite 110; menlo park CA 94025
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19013036
• MDR Text Key: 339040379
• Report Number: 2124215-2024-19130
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2024

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: 1-21C-0086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1