BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY STENT W/ UNISTEP PLUS

    MDR report key: 1191929 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04950
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K982005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), A STENT LENGTH DISCREPANCY WAS NOTED. A 10X60 BILIARY ENDO WALLSTENT WAS ADVANCED TO A LESION IN THE COMMON BILE DUCT. "THE STENT IS 8 CENTIMETERS LONG INSTEAD OF 6 CENTIMETERS, THERE IS TOO MUCH STENT HANGING IN THE DUODENUM." THE STENT WAS REMOVED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY STENT W/ UNISTEP PLUS FGE BOSTON SCIENTIFIC H965430500

    Patients

    Seq Age Sex Outcome Treatment
    1