BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2022602 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00746
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 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). 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 HOLE AT THE DISTAL END OF THE PUSH CATHETER WAS TORN. THE SUTURE NOT RETURNED FOR EVALUATION. THE GUIDE CATHETER WAS STRETCHED NEAR THE PROXIMAL END AND WAS BUCKLED/KINKED CLOSE TO THE DISTAL END. ALTHOUGH THE GUIDE CATHETER WAS NOT BROKEN, THE DISTAL TIP OF THE GUIDE CATHETER WAS TORN. 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.

    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 DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT.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 BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER FLEXIMA BILIARY STENT SYSTEM WAS NOT AVAILABLE AT THE SITE. THERE WAS NO REPORTED PATIENT COMPLICATION. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

    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 DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT.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 BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER FLEXIMA BILIARY STENT SYSTEM WAS NOT AVAILABLE AT THE SITE. THERE WAS NO REPORTED PATIENT COMPLICATION. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

    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 M00539200

    Patients

    Seq Age Sex Outcome Treatment
    1