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

Model Number	M004PF61M402
Medical Device Problem Codes	Device Emits Odor (1425); Use of Device Problem (1670); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulse field ablation (pfa) procedure using a farastar generator the procedure was cancelled due to a system shut down.During the procedure the system shut down and could not be restarted.There was a burning odor coming from the generator.It was also reported that in multiple cases before the final case they received 306 catheter usage errors that needed to be bypassed.A field service engineer was sent to the sight and observed blown fuses and sparks from the hv printed circuit board that left burn marks inside the generator.The generator was then deinstalled from the site and has been received for analysis.
Additional Manufacturer Narrative
When the farastar generator was first received it was visually inspected and the hvp printed circuit board assembly (pcba) was found to have a crack and one of the components was blown with visible charring.All other pcbas and components of the generator were free from obvious visible damage.The generator was electrically tested and the main pcba board was found to be electrically faulty.Based on all available information boston scientific confirmers the allegation in the complaint.
Event or Problem Description
It was reported that during a pulse field ablation (pfa) procedure using a farastar generator the procedure was cancelled due to a system shut down.During the procedure the system shut down and could not be restarted.There was a burning odor coming from the generator.It was also reported that in multiple cases before the final case they received 306 catheter usage errors that needed to be bypassed.A field service engineer was sent to the sight and observed blown fuses and sparks from the hv printed circuit board that left burn marks inside the generator.The generator was then deinstalled from the site and is expected to be returned for analysis.

• 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: 22768867
• Report Number: 2124215-2025-55650
• Device Sequence Number: 21154490
• Product Code: QZI
• UDI-Device Identifier: 00191506043698
• UDI-Public: (01)00191506043698(11)250530
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: M004PF61M402
• Device Catalogue Number: M004PF61M402
• Device Lot Number: 0108663191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown