BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1823857 · Received September 2, 2010

    Report

    Report Number
    3005099803-2010-03707
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 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

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS LOADED ON THE GUIDE CATHETER VIA THE SUTURE. THE GUIDE CATHETER WAS STRETCHED AND BROKEN CLOSE TO THE PROXIMAL END. THE DISTAL BROKEN PIECE OF THE GUIDE CATHETER REMAINED WITHIN THE DELIVERY SYSTEM AND WAS KINKED/BENT/TWISTED BETWEEN THE GAP OF PUSH CATHETER AND STENT. THE DISTAL END OF GUIDE CATHETER ALSO HAD MULTIPLE KINKS/BENDS (SUTURE IMPRESSIONS). THE PROXIMAL END OF THE PUSH CATHETER WAS KINKED. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. 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 FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE BILE DUCT OF A (B)(6) OLD FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE ATTEMPT TO DEPLOY THE STENT, THE GUIDE CATHETER 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 COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE 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 ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE BILE DUCT OF (B)(6) FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE ATTEMPT TO DEPLOY THE STENT, THE GUIDE CATHETER 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 COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE 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 M00539220 13473890

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR