BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER?

    MDR report key: 23622840 · Received November 21, 2025

    Report

    Report Number
    2124215-2025-85715
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729804666
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN 8.0 X40, 135CM CHARGER WAS SELECTED FOR USE IN ANGIOPLASTY. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076692 CHARGER? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206080410 0036153592 08714729804666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown