BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER

    MDR report key: 20768088 · Received November 24, 2024

    Report

    Report Number
    2124215-2024-74082
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729804246
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 11/01/2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. D2B - ADDITIONAL PRO CODE (PRODUCT CODE): LIT. G4 - ADDITIONAL PREMARKET / 510(K): K112701, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURED. A 5.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623062 CHARGER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206050410 0030542225 08714729804246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown