BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2220375 · Received August 11, 2011

    Report

    Report Number
    2220375
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    AS THE STENT WAS BEING ADVANCED THROUGH THE SEVEN FRENCH SHEATH OVER THE WIRE TO TARGET THE RIGHT COMMON ILIAC, THE STENT CAME OFF DEPLOYMENT BALLOON IN THE R ILIAC. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BY REMOVING THE SHEATH. THE UNDEPLOYED STENT REMAINED IN THE RIGHT ILIAC UNTIL A SMALL BALLOON WAS ABLE TO BE INSERTED OVER THE WIRE AND THROUGH THE STENT. THE STENT WAS DEPLOYED IN RIGHT ILIAC. A SECOND STENT WAS ABLE TO BE PASSED THROUGH THE RIGHT ILIAC STENT AND PLACED IN THE TARGET ARTERTY, THE RIGHT COMMON ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOSTON SCIENTIFIC EXPRESS BILIARY LD OVER WIRE 10MM X 57MM X FGE BOSTON SCIENTIFIC 38946-10607 13036730

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR