BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1832635 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03909
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 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

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDE CATHETER WAS BROKEN/SEPARATED FROM THE PULLWIRE. THE PULLWIRE WAS KINKED NEAR THE RAMP WINDOW. THE STENT WAS NOT RETURNED FOR EVALUATION. A FUNCTIONAL EVALUATION REVEALED THAT WHEN THE HANDLE WAS ACTUATED (EXTENDED AND RETRACTED), IT DID NOT FUNCTION SMOOTHLY DUE TO THE KINKED PULLWIRE. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE EVENT DESCRIPTION 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.

    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 A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING A DRAINAGE PROCEDURE IN THE BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). AFTER THE STENT WAS LOADED ONTO THE DELIVERY, THE GUIDE CATHETER SEPARATED FROM THE DELIVERY SYSTEM AS IT WAS BEING INSERTED INTO THE SCOPE CHANNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM AND NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    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, AND WEIGHT ARE UNKNOWN). AFTER THE STENT WAS LOADED ONTO THE DELIVERY, THE GUIDE CATHETER SEPARATED FROM THE DELIVERY SYSTEM AS IT WAS BEING INSERTED INTO THE SCOPE CHANNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM AND 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 M00545560 13481950

    Patients

    Seq Age Sex Outcome Treatment
    1