BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1230998 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05548
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE INNER GUIDE CANNULA BUCKLED. AN RX STENT/7 X 10CM STENT HAD BEEN ADVANCED TO AN UNSPECIFIED TARGET LESION WITHIN THE COMMON BILE DUCT. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE INNER GUIDE CATHETER BUCKLED. THE DEVICE WAS REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545570 11523944

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR