BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER

    MDR report key: 22124784 · Received June 2, 2025

    Report

    Report Number
    2124215-2025-35708
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729804673
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K112697, K112701, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ECCENTRIC, NON-TORTUOUS AND MODERATELY CALCIFIED COMMON FEMORAL ARTERY. A 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR CLAUDICATION PROCEDURE. HOWEVER, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR <20 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A SMALLER 7X40 CHARGER BALLOON. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391118 CHARGER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206080470 0035540814 08714729804673

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown