BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1191868 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04959
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SHAFT KINK OCCURRED. THE 10 X 80 PERMALUME BILIARY STENT WAS REMOVED FROM THE PACKAGING, AND UPON INSPECTION, NO PROBLEMS WERE NOTED WITH THE DEVICE. THE DEVICE WAS PASSED THROUGH THE SCOPE AND WHILE ATTEMPTING TO DEPLOY THE STENT, IT WAS NOTED THAT A KINK HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERMALUME STENT. NO PT COMPLICATIONS OCCURRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720 0011403800

    Patients

    Seq Age Sex Outcome Treatment
    1