BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER

    MDR report key: 21707557 · Received March 27, 2025

    Report

    Report Number
    2124215-2025-18443
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729803799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K112697, K112701, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 10.0 X40, 75CM CHARGER WAS USED FOR DILATION. DURING THE PROCEDURE, A SUCCESSFUL ANGIOGRAPHY WITH A 6 FRENCH SHEATH, WAS PERFORMED AND THE LESION WAS CROSSED WITH A WIRE. IVUS WAS ALSO SUCCESSFULLY PERFORMED. HOWEVER, THERE WAS A LEAK AT THE BALLOON PACKAGE OPENING, PREVENTING BALLOON DILATION. THE BALLOON RUPTURED ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407777 CHARGER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206100470 0033063854 08714729803799

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male