MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR?; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Model Number	M004PF61M401
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure cancelled occurred.It was reported that a farastar generator was selected.During procedure, an error 301 was displayed when it was attempted to deliver pulse field ablation (pfa).No mapping system module (msm) was being used.Troubleshooting was performed, it was attempted to restart the device, change catheter and catheter cable, but the issue persisted.The procedure was not completed due to this issue.There was no patient complication reported.A field service engineer arrived on site, and the reported issue was confirmed.The unit was powered off and disassembled and removed faulty high voltage (hv) master board and installed new one in accordance.The unit was powered on and input new calibration measurements.Functional checks were performed and the unit passed all checks, and it was confirmed that is ready for clinical use.Product return is expected.
Additional Manufacturer Narrative
D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.

• Brand Name: FARASTAR?
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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 -579
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50896591
• Report Number: 2124215-2026-51135
• Device Sequence Number: 16142851
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: (01)00191506042882(11)240809
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P230030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 0105670249
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown