BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2071733 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01380
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS INTACT AT THE DISTAL END OF PUSH CATHETER. THE SUTURE WAS DISCOLORED LIKELY DUE TO THE USAGE OF THE DEVICE. THE GUIDE CATHETER WAS RECEIVED INSIDE THE DELIVERY SYSTEM. THE TOUHY BORST ADAPTER WAS RECEIVED LOOSENED AND REMAINED INTACT ON THE GUIDE CATHETER. DURING THE EVALUATION, THE GUIDE CATHETER WAS REMOVED FROM THE DELIVERY SYSTEM. THE WORKING LENGTH OF THE GUIDE CATHETER WAS NOT STRETCHED OR BROKEN. THE DISTAL TIP OF THE GUIDE CATHETER WAS TORN/SPLIT. THE DISTAL END OF THE GUIDE CATHETER WAS KINKED (SUTURE IMPRESSION). THERE WAS NO DAMAGE TO THE PUSH CATHETER AND 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

    (B)(4):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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A (B)(6). DURING THE PROCEDURE, AS THE PHYSICIAN WAS ADVANCING THE DELIVERY SYSTEM TO THE TARGET SITE, THE STENT PREMATURELY DEPLOYED AT THE INCORRECT SITE. THE STENT WAS REMOVED FROM WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM. THERE WERE 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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A (B)(6) MALE WEIGHING (B)(6). DURING THE PROCEDURE, AS THE PHYSICIAN WAS ADVANCING THE DELIVERY SYSTEM TO THE TARGET SITE, THE STENT PREMATURELY DEPLOYED AT THE INCORRECT SITE. THE STENT WAS REMOVED FROM WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM. THERE WERE 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 M00539210 13455477

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR