BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1882024 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04483
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 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 WORKING LENGTH OF THE GUIDE CATHETER WAS FOUND STRETCHED AND KINKED AT MULTIPLE LOCATIONS. THE WORKING LENGTH OF THE GUIDE CATHETER WAS NOT BROKEN. THE HUB OF GUIDE CATHETER WAS DETACHED/SEPARATED AND WAS NOT RETURNED FOR EVALUATION. THE PUSH CATHETER AND STENT WERE NOT RETURNED FOR EVALUATION. THE RETURNED PRODUCT COMPRISED OF GUIDE CATHETER ASSEMBLY ONLY. 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. THE EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE WORKING LENGTH OF THE GUIDE CATHETER WAS NOT BROKEN. ALTHOUGH THE GUIDE CATHETER HUB (MOLDED HANDLE/LUER) ON THE FLEXIMA WAS SEPARATED, THIS COMPONENT SEPARATION CANNOT ENTER THE BODY. THEREFORE, THE EVENT IS DETERMINED TO BE NON MDR REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS (B)(6). 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 STENT PLACEMENT PROCEDURE IN THE BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED IN AN ATTEMPT TO DEPLOY THE STENT. THE GUIDE CATHETER STRETCHED AND BROKE. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. THE GUIDE CATHETER AND THE ZEON GUIDEWIRE WERE RETRACTED AT THE SAME TIME AND THE STENT WAS DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 STENT PLACEMENT PROCEDURE IN THE BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED IN AN ATTEMPT TO DEPLOY THE STENT. THE GUIDE CATHETER STRETCHED AND BROKE. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. THE GUIDE CATHETER AND THE (B)(4) GUIDEWIRE WERE RETRACTED AT THE SAME TIME AND THE STENT WAS DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 M00539260 13361019

    Patients

    Seq Age Sex Outcome Treatment
    1 ZEON GUIDEWIRE| SCOPE: (B)(4)