BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2031788 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00922
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 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

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY (B)(6). (B)(4) RELATES TO (B)(4) FOR THE ISSUE OF GUIDE CATHETER BROKEN. 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 SUTURE WAS DETACHED/SEPARATED FROM THE DISTAL END OF PUSH CATHETER AND WAS NOT RETURNED FOR EVALUATION. THE SUTURE HOLE WAS SLIGHTLY TORN. THE WORKING LENGTH OF THE PUSH CATHETER WAS KINKED. THE GUIDE CATHETER WAS STRETCHED NEAR THE PROXIMAL END, BUT WAS NOT BROKEN AND WAS FOUND INSIDE THE PUSH CATHETER. THE TIP OF THE GUIDE CATHETER WAS FOUND JAGGED/TORN. DURING THE EVALUATION, THE GUIDE CATHETER WAS REMOVED FROM THE PUSH CATHETER BY RETRACTING FROM THE PROXIMAL END. THE DISTAL END OF THE GUIDE CATHETER WAS KINKED/BENT (SUTURE IMPRESSION). THE STENT WAS NOT RETURNED FOR EVALUATION. 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 STENTING 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 DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE CATHETER STRETCHED, BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM. 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 BILE DUCT OF A PATIENT (PATIENT AGE, SEX, 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 PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM. 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 M00539220 13982437

    Patients

    Seq Age Sex Outcome Treatment
    1