BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER?

    MDR report key: 23569392 · Received November 17, 2025

    Report

    Report Number
    2124215-2025-83442
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729804697
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A BALLOON RUPTURE OCCURRED. A 8.0 X 80, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296031 CHARGER? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206080810 0031452840 08714729804697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown