BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1822885 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03578
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    June 9, 2010
    Report Date
    August 11, 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

    (B)(4): A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THE STENT WAS KINKED/BENT. THE DISTAL AND PROXIMAL TIP OF THE STENT WAS COLLAPSED LIKELY DUE TO SHIPPING/HANDLING/USAGE OF THE DEVICE. THE PULLWIRE AT THE RAMP WINDOW WAS KINKED AND PUSHED OUT/DISLODGED FROM THE RAMP WINDOW. THE RAMP WAS SLIGHTLY TORN/DAMAGED. THE GUIDE CATHETER WAS KINKED THROUGHOUT THE WORKING LENGTH. A FUNCTIONAL EVALUATION WAS CONDUCTED BY EXITING A 0.035" GUIDEWIRE THROUGH THE RAMP WINDOW WITH NO DIFFICULTIES. THE DEVICE WITH THE LOADED STENT WAS INSERTED INSIDE A 3.2MM ENDOSCOPE AND NO RESISTANCE WAS OBSERVED. THE GUIDE CATHETER AND STENT EXITED THE DISTAL TIP OF THE ENDOSCOPE WITHOUT ANY ISSUES. THE OUTER DIAMETER OF THE STENT MET THE SPECIFICATION OF 0.112" +/- 0.006". BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE COMPLAINT FILE DETAILS AND PRODUCT ANALYSIS DO NOT PROVIDE SUFFICIENT INFORMATION TO CONCLUDE A PROBABLE ROOT CAUSE FOR THE COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING A STONE REMOVAL PROCEDURE OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE ADVANCED THROUGH THE SCOPE AS IT GOT STUCK IN THE SCOPE. THE SCOPE WAS REMOVED FROM THE PATIENT (TO PREVENT ANY DAMAGE TO THE SCOPE) AND THE DEVICES (STENT SYSTEM AND GUIDEWIRE) WERE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE SAME SCOPE, GUIDEWIRE AND ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; DEFORMED AND KINKED STENT.

    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 13382053

    Patients

    Seq Age Sex Outcome Treatment
    1 SCOPE : (B)(4) (OLYMPUS)