BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2013430 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00636
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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 THAT THE STENT WAS STILL ATTACHED VIA THE UNBROKEN SUTURE. THE PUSH CATHETER WAS KINKED NEAR THE HUB. THE SUTURE HOLE WAS TORN ON THE DISTAL END OF THE PUSH CATHETER. THE GUIDE CATHETER WAS STRETCHED AND BROKEN. DURING THE INVESTIGATION, THE SUTURE WAS CUT AND THE STENT RELEASED. THE GUIDE CATHETER REVEALED SUTURE LIGATURE MARKS. THERE WAS NO DAMAGE TO THE STENT. 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 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 FEMALE PATIENT (PATIENT AGE 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 DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT.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 ENDED WITHOUT A STENT AS THE PHYSICIAN WAS UNABLE TO CROSS THE STRICTURE A SECOND TIME WITH THE OLYMPUS VISIGLIDE GUIDEWIRE. THERE WERE 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 FEMALE PATIENT (PATIENT AGE 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 ENDED WITHOUT A STENT AS THE PHYSICIAN WAS UNABLE TO CROSS THE STRICTURE A SECOND TIME WITH THE OLYMPUS VISIGLIDE GUIDEWIRE. THERE WERE 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 M00539210 13592683

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: OLYMPUS VISIGLIDE