BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2001232 · Received February 24, 2011

    Report

    Report Number
    3005099803-2011-00451
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    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 EXAMINATION OF THE RETURNED DEVICE REVEALED THE STENT TO STILL BE ATTACHED TO THE DELIVERY SYSTEM. THE STENT WAS WITHOUT ISSUE. THE SUTURE WAS ATTACHED AND UNBROKEN. THE PUSH CATHETER WAS KINKED AND THE SUTURE HOLE WAS TORN. THE GUIDE CATHETER WAS STRETCHED, KINKED AND BROKEN. THE PROXIMAL PORTION OF THE GUIDE CATHETER WAS STUCK ON THE GUIDEWIRE. THE GUIDEWIRE PRESENTED NO ISSUES. THE DISTAL PORTION OF THE GUIDE CATHETER COULD NOT BE FULLY PULLED OUT OF THE PUSH CATHETER. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT.A DEVICE HISTORY RECORD (DHR) AND A REVIEW OF SIMILAR COMPLAINTS COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(6): 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 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 FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A STENTING PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE CATHETER STRETCHED, BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE.THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE (DEVICE AND MANUFACTURE NAME UNAVAILABLE) WITH 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 FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A STENTING PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE CATHETER STRETCHED, BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE (DEVICE AND MANUFACTURE NAME UNAVAILABLE) 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 M00539200

    Patients

    Seq Age Sex Outcome Treatment
    1