MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; SEE H11

Model Number	M004PF61M402
Medical Device Problem Codes	Nonstandard Device (1420); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, while performing ablation at the lipv using the farawave catheter, error code 322 appeared on the farastar touchscreen after pressing the deliver button; despite repeating the prepare > confirm > deliver workflow and following troubleshooting steps, the error persisted, and after restarting the farastar generator, error code 201 was displayed during the startup self-test.As a result, the procedure had to be cancelled and could not be continued.No further information was provided.There is not any indication if the device will be returned.
Additional Manufacturer Narrative
Full common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation.

• Brand Name: FARASTAR
• Common Device Name: SEE H11
• 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: 25446819
• Report Number: 2124215-2026-30356
• Device Sequence Number: 21221721
• Product Code: QZI
• UDI-Device Identifier: 00191506043698
• UDI-Public: (01)00191506043698(11)260212
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: M004PF61M402
• Device Catalogue Number: M004PF61M402
• Device Lot Number: 0111351858
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male