BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1221541 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06054
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SUTURE WAS TORN. THE TARGET LESION WAS IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE 7FR/12CM FLEXIMA BILIARY STENT, IT WAS UNABLE TO SLIDE THROUGH THE GUIDE CATHETER. WHEN IT WAS PULLED THROUGH THE GUIDE CATHETER WITH FORCE, THE SUTURE TORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. NO PT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC NA 11694701

    Patients

    Seq Age Sex Outcome Treatment
    1