BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY STENT W/UNISTEP PLUS

    MDR report key: 1181673 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04933
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K982005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE, THE BILIARY WALLSTENT WAS LONGER THAN LABELED. FOLLOWING PLACEMENT IN THE COMMON BILE DUCT, THE PHYSICIAN NOTED THAT THE STENT WAS 8CM LONG VERSUS 6CM, AS LABELED. THE STENT WAS PROTRUDING INTO THE DUODENUM. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1