BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1213727 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05431
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL, THEREFORE, THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNK. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DEPLOYMENT DIFFICULTY OCCURRED. THE 10 FR/12 CM FLEXIMA BILIARY STENT WAS ADVANCED TO THE TARGET LESION. WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, "IT WAS STRETCHED, THE INNER SHEATH". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1