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

Model Number	M004PF61M401
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that following a pulse field ablation (pfa) procedure using a farastar pulse field ablation generator the patient's pacemaker was no longer responsive.Prior to the procedure the patient's implantable cardiac defibrillator was programed to disable tachycardia therapy and was double checked to ensure it would not respond during the procedure.Ablations were performed in the left atrium and along the cti.After the ablation procedure was completed, the nurse attempted to interrogate the patient's icd but was unable to do so.It was discovered that the patient's icd was no longer functioning properly and the patient was left unprotected.The patient underwent surgery later that day to replace their icd and was hospitalized.The patient has recovered without further reported complications.

• 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: 23885338
• Report Number: 2124215-2025-92850
• Device Sequence Number: 11929544
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: (01)00191506042882(11)240716
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/12/2026

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: 0105581623
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown