BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1960537 · Received January 13, 2011

    Report

    Report Number
    3005099803-2011-00050
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 14, 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 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 BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FLEXIMA BILIARY STENT SYSTEM INTO THE BILE DUCT. THE DEVICE WAS REMOVED FROM THE PATIENT AND A KINK WAS NOTED ON THE TIP OF THE GUIDE CATHETER. THERE WERE NO REPORTED PRODUCT ANAMOLIES PRIOR TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE. ON (B)(6), 2011 IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE STENT DEVICE HAD DIFFICULTY ADVANCING THROUGH THE ENDOSCOPE. IT WAS CONFIRMED THAT THE STENT DEVICE NEVER EXITED THE ENDOSCOPE AND THEREFORE, THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND THE ENDOSCOPE WAS NOT IN A BENT OR KINKED POSITIONED. BASED ON THIS ADDITIONAL INFORMATION RECEIVED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE.

    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, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FLEXIMA BILIARY STENT SYSTEM INTO THE BILE DUCT. THE DEVICE WAS REMOVED FROM THE PATIENT AND A KINK WAS NOTED ON THE TIP OF THE GUIDE CATHETER. THERE WERE NO REPORTED PRODUCT ANAMOLIES PRIOR TO USE.THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE 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 M00539270 13676059

    Patients

    Seq Age Sex Outcome Treatment
    1