BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1895411 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04705
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ALTHOUGH THE LOT NUMBER IS UNKNOWN, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING A DRAINAGE PROCEDURE IN THE BILE DUCT OF A PATIENT (PATIENT AGE, SEX, WEIGHT AND EVENT DATE ARE UNKNOWN). DURING THE PREPARATION, IT WAS NOTED THE PROXIMAL END OF THE STENT WAS DEFORMED. THERE WAS NO DAMAGE TO THE PACKAGE/POUCH. THE DEVICE WAS NOT USED AND THE PROCEDURE COMPLETED WITH ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545580

    Patients

    Seq Age Sex Outcome Treatment
    1