BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY SD-MONORAIL

    MDR report key: 1183503 · Received September 23, 2008

    Report

    Report Number
    1183503
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    AS THE STENT WAS ADVANCED THROUGH THE SHEATH TO THE AREA OF STENOSIS, THE STENT/BALLOON ASSEMBLY WOULD NOT ADVANCE DESPITE THE PREDILATION. THE STENT COULD NOT BE PULLED BACK INTO THE SHEATH. THE STENT CAME OFF OF THE BALLOON WHILE STILL IN THE SHEATH, RESULTING IN DEPLOYMENT INTO THE RIGHT EXTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE WELL WITH MUCH IMPROVED BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD-MONORAIL STENT, BILIARY FGE BOSTON SCIENTIFIC CORPORATION * 11793894

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR