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

Model Number	M004PF61M401
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a pulsed field ablation (pfa) procedure a farastar pfa generator was selected for use.After delivering 67 applications, the console displayed the 301 error.The catheter and cable were replaced, it was attempted to bypass the catheter but the issue persisted.The procedure had to be cancelled due to this issue.This complaint is being reported due to an aborted procedure with the patient under sedation.
Additional Manufacturer Narrative
The device has been received for analysis.The returned farastar master pcba within the generator was confirmed to have electrical defects.Service history review: a service history review was performed.The reported device was installed on (b)(6) 2024.There were no cases or complaints created after that date and prior to the currently reported event date to suggest performance issues that could have caused or contributed to the reported event.The reported device was, therefore, considered fully functional with no issues from that date until the currently reported event date.Labeling review: review of the complaint information and the instructions for use did not reveal any evidence of device off-label use or failure to follow instructions.Additionally, there are no directions in the instructions for use that could cause the failure observed.There is no evidence that any updates to the document are required at this time.Risk review: a risk review was performed.The complaint type does not present a new or unanticipated failure type or harm.This is documented with a hazardous situation of "ablation delivery is inhibited until the condition is corrected" and harm "additional intervention required" with a severity of 3 and an occurrence of 3.This line item was selected due to the procedure being cancelled while the patient was sedated.No further review is required.The "manufacturing deficiency" conclusion code was selected as the gigavac relay for channel 5 was not working properly on the master pcba.
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure a farastar pfa generator was selected for use.After delivering 67 applications, the console displayed the 301 error.The catheter and cable were replaced, it was attempted to bypass the catheter but the issue persisted.The procedure had to be cancelled due to this issue.This complaint is being reported due to an aborted procedure with the patient under sedation.

• 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: 22475477
• Report Number: 2124215-2025-46196
• Device Sequence Number: 8184548
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: (01)00191506042882(11)240409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/08/2026

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: 0104556521
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown