BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 21246306 · Received January 27, 2025

    Report

    Report Number
    2124215-2025-03368
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729390473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE BECAME WRAPPED WITH THE STENT AND BROKE OFF, REQUIRING SNARE FOR REMOVAL. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR MESENTERIC STENTING. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT AND WIRE BECAME WRAPPED AND BROKE OFF. THE BROKEN PIECES OF THE STENT AND WIRE WERE SNARED OUT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606542 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937912519150 0033343441 08714729390473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention