MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004PF61M401
Medical Device Problem Codes	Off-Label Use (1494); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a persistent atrial fibrillation (off-label use) pulse field ablation (pfa) procedure a farastar generator was selected for use.During procedure, after two applications of pfa in the 301-errors were reported.Troubleshooting was performed, the generator was restarted without success.It was attempted to reposition in the pulmonary vein to rule out anatomy challenges and replacement of the catheter, but the 301-error persisted.Since the error could not be solved the procedure was aborted.At the time of the error no patient complications were reported.The device is expected to be returned.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional 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.
Additional Manufacturer Narrative
Correction to device codes, removal of code a2304: off label use.The device was not returned.However, the allegation(s) reported in the complaint are confirmed per field service work order, "replaced defective hv master pcba" and a performed functional test was successfully performed.
Event or Problem Description
During a persistent atrial fibrillation (off-label use) pulse field ablation (pfa) procedure a farastar generator was selected for use.During procedure, after two applications of pfa in the 301-errors were reported.Troubleshooting was performed; the generator was restarted without success.It was attempted to reposition in the pulmonary vein to rule out anatomy challenges and replacement of the catheter, but the 301-error persisted.Since the error could not be solved the procedure was aborted.At the time of the error no patient complications were reported.The device is expected to be returned.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: FARASTAR
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20687050
• Report Number: 2124215-2024-71675
• Device Sequence Number: 7230023
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: 00191506042882
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: M004PF61M401
• Device Catalogue Number: M004PF61M401
• Device Lot Number: 0105087079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown