BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1864479 · Received October 12, 2010

    Report

    Report Number
    3005099803-2010-04327
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 24, 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 STENT WAS RECEIVED SEPARATED FROM THE DELIVERY SYSTEM. THE GUIDE CATHETER WAS COMPLETELY INSIDE THE DELIVERY SYSTEM AND WAS UNRETRACTED. THE GUIDE CATHETER WAS NOT STRETCHED OR BROKEN. THE DISTAL END OF THE GUIDE CATHETER HAD A KINK/BEND (SUTURE IMPRESSION). THE SUTURE WAS INTACT (UNBROKEN) AT THE DISTAL END OF THE PUSH CATHETER. THERE WERE NO VISIBLE DAMAGES ON THE STENT OR THE WORKING LENGTH OF THE PUSH CATHETER. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. 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 BILIARY STENT PLACEMENT PROCEDURE ON A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, AS THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE COMMON BILE DUCT, THE DEVICE ADVANCED TO AN INCORRECT POSITION. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT; HOWEVER THE STENT SPONTANEOUSLY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA 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 FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE ON A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, AS THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE COMMON BILE DUCT, THE DEVICE ADVANCED TO AN INCORRECT POSITION. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT; HOWEVER, THE STENT SPONTANEOUSLY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA 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 M00539230 13441019

    Patients

    Seq Age Sex Outcome Treatment
    1