BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1133470 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03834
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED, THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED. THE 2008, RX BILIARY PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE EIGHT DAYS LATER. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THERE WAS DIFFICULTY LOADING STENT OVER REPLACED GUIDEWIRE. PROCEDURE SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORPORATION M00545550 11188334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK