BEUDAMED
    FDA Adverse Event Other Summary report: N

    FANELLI BILIARY STENT SET

    MDR report key: 502540 · Received December 10, 2003

    Report

    Report Number
    1820334-2003-00256
    Event Type
    Other
    Date Received
    December 10, 2003
    Date of Event
    November 7, 2003
    Report Date
    November 10, 2003
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE STENT WAS PLACED AND WHEN PULLING BACK THE INNER CANNULA, THE MARKERS SHEARED OFF THE CANNULA AND REMAINED IN THE STENT. THE PHYSICIAN DID AN ERCP ON THE PATIENT AND THE STENT WAS REMOVED. ALL THREE MARKERS WERE WITHIN THE STENT LUMEN UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FANELLI BILIARY STENT SET BILIARY STENT FGE COOK, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other