BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2133968 · Received June 20, 2011

    Report

    Report Number
    3005099803-2011-02108
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS THE COMPLAINT DEVICE WAS RETURNED IN ITS UNOPENED PACKAGE. THE RETURNED PACKAGE WAS VISUALLY EXAMINED WITHOUT MAGNIFICATION UNDER NORMAL LIGHTING CONDITIONS AT AN ARMS LENGTH. BLACK POWDERY TYPE MATERIAL WAS FOUND INSIDE THE POUCH, LOCATED IN THE LOWER CORNERS AND NEAR THE MIDDLE OF THE POUCH. ANALYSIS OF THE BLACK MATERIAL REVEALED THAT THE PARTICLES WERE METALLIC IN NATURE AND MAINLY COMPRISED OF ALUMINIUM ELEMENT. THE FOREIGN MATERIAL DID NOT APPEAR TO HAVE BEEN GENERATED FROM ANY METALLIC COMPONENTS OF THE DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE. BASED ON THE CONDITION OF THE RETURNED PRODUCT, THE COMPLAINT THAT BLACK POWDER WAS NOTED INSIDE THE PACKAGING WAS CONFIRMED. IT IS UNKNOWN WHETHER MANUFACTURING OF THE DEVICE INCLUDING PACKAGING PROCESSES OR SUPPLIER MANUFACTURING/SHIPPING/HANDLING CONTRIBUTED TO THIS EVENT; THEREFORE THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN 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 BLACK POWDER MATERIAL WAS NOTED IN THE CORNER OF THE TRAY OF AN UNOPENED/UNUSED FLEXIMA RX BILIARY STENT SYSTEM. THE BLACK POWDER MATERIAL WAS NOTED IN THE UNOPENED/UNUSED FLEXIMA RX BILIARY STENT SYSTEM WHILE IN THE HOSPITAL STOCK. THE COMPLAINANT REPORTED NO DAMAGE NOTED TO THE PACKAGING AND THE SEAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT BLACK POWDER MATERIAL WAS NOTED IN THE CORNER OF THE TRAY OF AN UNOPENED/UNUSED FLEXIMA RX BILIARY STENT SYSTEM. THE BLACK POWDER MATERIAL WAS NOTED IN THE UNOPENED/UNUSED FLEXIMA RX BILIARY STENT SYSTEM WHILE IN THE HOSPITAL STOCK. THE COMPLAINANT REPORTED NO DAMAGE NOTED TO THE PACKAGING AND THE SEAL.

    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 M00545660 14111288

    Patients

    Seq Age Sex Outcome Treatment
    1