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

Model Number	M004PF41M434
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that for a pulse field ablation (pfa) procedure to treat an atrial fibrillation, upon opened packaging, scrub tech removed cable and debris noted within package.The device was replaced, and the procedure was completed successfully.No patient complications were reported.The device isn't expected to return for laboratory analysis.
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.

• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21875534
• Report Number: 2124215-2025-25058
• Device Sequence Number: 7719242
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(17)270114(10)35623216
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/21/2025

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: M004PF41M434
• Device Catalogue Number: M004PF41M434
• Device Lot Number: 0035623216
• 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: 03/26/2025
• Initial Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown