BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22345019 · Received June 27, 2025

    Report

    Report Number
    2124215-2025-42785
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, HOWEVER 1 MEDIA WAS PROVIDED. ONCE THE MEDIA IS EVALUATED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VISIBLE AIR BUBBLES OCCURRED. DURING A PROCEDURE, THE FARADRIVE STEERABLE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. THE NON-BOSTON SCIENTIFIC OCTARAY WAS USED FOR MAPPING, AND THE FARAWAVE CATHETER WAS UTILIZED FOR ABLATION. UPON RE-MAPPING WITH THE OCTARAY, IT WAS OBSERVED THAT THE VALVE AT THE PROXIMAL END OF THE SHEATH WAS LEAKING AIR DURING ASPIRATION. THE ANOMALY WAS OBSERVED AT THE END OF THE PROCEDURE; THEREFORE, THE SHEATH WAS NOT REPLACED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED. 1 MEDIA WAS PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939407 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL13913 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown