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

Lot Number 0103241061

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the farastar ablation generator had recurring errors while in use for treatment with a patient.After multiple 301 errors, the error f-0x201: main post failure occurred.A reset was made on the generator but this did not resolve the errors, therefore, a different generator was attempted to be used for the procedure.The procedure was not completed.No patient complication occurred.The device will not be returned as repairs will be performed onsite.

Manufacturer Narrative

The device has not been received for analysis.However, a field service was performed, and a master board swap and complete system check was conducted.

Event Description

It was reported that the farastar ablation generator had recurring errors while in use for treatment with a patient.After multiple 301 errors, the error f-0x201: main post failure occurred.A reset was made on the generator but this did not resolve the errors, therefore, a different generator was attempted to be used for the procedure.The procedure was not completed.No patient complication occurred.The device will not be returned as repairs will be performed onsite.

• 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): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18794481
• MDR Text Key: 336548632
• Report Number: 2124215-2024-11801
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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,Followup
• Report Date: 03/19/2024

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: 0103241061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1