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

Model Number	M004PF61M401
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulse field ablation procedure with a farastar console the monitor was blank, but has some functionality, the unit was rebooted, but the issue persisted.The cable connection was checked, back/under monitor and all was secure and cables look physically fine.Bad monitor or video card is suspected.System monitor went blank during use.Several restarts were done but the video would not return.The case was aborted.The product is returned for laboratory analysis.This event is being reported for aborted/cancelled procedure.
Additional Manufacturer Narrative
Additional information added to b5: describe event or problem.
Event or Problem Description
It was reported that during a pulse field ablation procedure with a farastar console the monitor was blank, but has some functionality, the unit was rebooted, but the issue persisted.The cable connection was checked, back/under monitor and all was secure and cables look physically fine.Bad monitor or video card is suspected.System monitor went blank during use.Several restarts were done but the video would not return.The case was aborted.The product is returned for laboratory analysis.This event is being reported for aborted/cancelled procedure.It was further reported that the patient was sedated and access was performed with the a faradrive sheath.
Additional Manufacturer Narrative
The returned farastar generator graphics card was inspected for damage and defects.No physical damage or major visual defects were observed.The returned farastar generator graphics card was installed in a known good generator for functional testing.The generator was power cycled a total of 5 times and was confirmed to boot each time with no issues or unexpected behaviors observed.The reported display issues could not be reproduced.The boot logs were reviewed and no issues were found.All expected files were found and confirmed to be uncorrupted.
Event or Problem Description
It was reported that during a pulse field ablation procedure with a farastar console the monitor was blank, but has some functionality, the unit was rebooted, but the issue persisted.The cable connection was checked, back/under monitor and all was secure and cables look physically fine.Bad monitor or video card is suspected.System monitor went blank during use.Several restarts were done but the video would not return.The case was aborted.The product is returned for laboratory analysis.This event is being reported for aborted/cancelled procedure.It was further reported that the patient was sedated and access was performed with the a faradrive sheath.

• 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: 23310870
• Report Number: 2124215-2025-73792
• Device Sequence Number: 17589595
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: (01)00191506042882(11)240321
• 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,Followup
• Report Date (Section B): 01/30/2026

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: 0104297663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 01/29/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/31/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown