BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1111623 · Received August 13, 2008

    Report

    Report Number
    3005099803-2008-02181
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF AN UNSPECIFIED GASTRO-INTESTINAL (GI) PROCEDURE, TRACKING DIFFICULTIES AND A PREMATURE STENT DEPLOYMENT OCCURRED. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). AN UNSPECIFIED GUIDE WIRE WAS PLACED. UPON LOADING THE RX WALLSTENT BILIARY 8MM X 60MM STENT DELIVERY SYSTEM (SDS) ONTO THE GUIDE WIRE, THE GUIDE WIRE WAS UNABLE TO EXIT FROM THE GUIDE WIRE ACCESS PORT. "BECAUSE OF THE CONDITION [OF THE DEVICE], THE PHYSICIAN HAD TO PEEL THE PORT" IN ORDER TO ALLOW THE GUIDE WIRE TO ADVANCE THROUGH THE ACCESS PORT. UPON INSPECTION OF THE DEVICE, THE PHYSICIAN "ACCIDENTALLY DEPLOYED THE STENT". A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX WALLSTENT BILIARY ENDOPROSTHESIS METAL STENT FGE BOSTON SCIENTIFIC M00569620 0011679408

    Patients

    Seq Age Sex Outcome Treatment
    1