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

Model Number	M004PF41M434
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulsed field ablation (pfa) procedure to treat an atrial fibrillation a farastar catheter connection cable presented an issue.When the package was opened, it was observed a shiny, glue-like substance adhered to the cable.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory where it's waiting for analysis.
Event or Problem Description
During a pulsed field ablation (pfa) procedure to treat an atrial fibrillation a farastar catheter connection cable presented an issue.When the package was opened, it was observed a shiny, glue-like substance adhered to the cable.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.
Additional Manufacturer Narrative
The device has been received for analysis.Upon device return and inspection, the reported shiny, glue-like substance was observed on the cable.Based on the performed analytical testing, the first fiber foreign material (fm) is consistent with keratin.The suspected adhesive fm is consistent with polypropylene glycol, and the second fiber fm is consistent with a cellulosic material.The 'quality control deficiency' conclusion code was selected based on analysis of the returned device.

• 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: 21961807
• Report Number: 2124215-2025-28306
• Device Sequence Number: 18454735
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(17)270205(10)35786299
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/01/2025

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: 0035786299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown