MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARASTAR; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR

Model Number	M004PF61M401
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a farastar generator was selected for use.A farastar 301 error occurred, and troubleshooting steps included repositioning the catheter, changing the catheter and cable, but the error persisted.The generator was power cycled and moved to another hospital-grounded power outlet, yet the error remained.Consequently, the procedure was not completed, and it is unknown if the patient was sedated.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
On january 24, 2025, a field service engineer visited the site, replaced the hv master pcba, updated the calibration data, and completed functional testing.The system is now in good working condition.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Additional information added to b5: describe event or problem.On (b)(6) 2025, a field service engineer visited the site, replaced the hv master pcba, updated the calibration data, and completed functional testing.The system is now in good working condition.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a farastar generator was selected for use.A farastar 301 error occurred, and troubleshooting steps included repositioning the catheter, changing the catheter and cable, but the error persisted.The generator was power cycled and moved to another hospital-grounded power outlet, yet the error remained.Consequently, the procedure was not completed, and it is unknown if the patient was sedated.On (b)(6) 2025, a field service engineer visited the site, replaced the hv master pcba, updated the calibration data, and completed functional testing.The system is now in good working condition.Additional information revealed that the patient was under general anesthesia at the time of the event.
Event or Problem Description
It was reported that a farastar generator was selected for use.A farastar 301 error occurred, and troubleshooting steps included repositioning the catheter, changing the catheter and cable, but the error persisted.The generator was power cycled and moved to another hospital-grounded power outlet, yet the error remained.Consequently, the procedure was not completed, and it is unknown if the patient was sedated.On (b)(6) 2025, a field service engineer visited the site, replaced the hv master pcba, updated the calibration data, and completed functional testing.The system is now in good working condition.Additional information revealed that the patient was under general anesthesia at the time of the event.
Additional Manufacturer Narrative
On (b)(6) 2025, a field service engineer visited the site, replaced the hv master pcba, updated the calibration data, and completed functional testing.The system is now in good working condition.Upon receipt at our post market quality assurance laboratory.The farastar master pcba was inspected for damage and defects.No physical damage or major visual defects were observed.The returned farastar master pcba was installed in a known good generator for functional testing.Generator was powered and passed post with no errors.A set of 5 ablations was performed with no issues or unexpected behaviors observed.

• Brand Name: FARASTAR
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR
• 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: 21324145
• Report Number: 2124215-2025-06327
• Device Sequence Number: 7866091
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: 00191506042882
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: 0103745438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 08/04/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 06/13/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown