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

Model Number	M004PF41M434
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information is in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
During a pulmonary vein isolation to treat an atrial fibrillation, a farastar catheter connection cable was selected for use.During preparation, it was noted that the paper on the packaging did not tear along the glued edges and instead became torn down the middle upon opening.Because the cable is packaged inside this without a tray the end of the cable fell out and touched an unsterile part of the packaging.The cable was replaced, and procedure was completed with no patient complications.The device is not expected to be returned as it was disposed.
Additional Manufacturer Narrative
Additional information added to d: suspect medical device.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
During a pulmonary vein isolation to treat an atrial fibrillation, a farastar catheter connection cable was selected for use.During preparation, it was noted that the paper on the packaging did not tear along the glued edges and instead became torn down the middle upon opening.Because the cable is packaged inside this without a tray the end of the cable fell out and touched an unsterile part of the packaging.The cable was replaced, and procedure was completed with no patient complications.The device is not expected to be returned as it was disposed.

• 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: 22152956
• Report Number: 2124215-2025-37073
• Device Sequence Number: 18092473
• Product Code: QZI
• UDI-Device Identifier: 00191506041656
• UDI-Public: (01)00191506041656(17)260805(10)34571366
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 08/05/2026
• Device Model Number: M004PF41M434
• Device Catalogue Number: M004PF41M434
• Device Lot Number: 0034571366
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown