BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1161573 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04527
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 18, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED BILIARY PROCEDURE, A SUTURE TEAR OCCURRED. UPON OPENING THE PACKAGE OF THE 7FR/7CM FLEXIMA BILIARY STENT, IT WAS NOTED THAT THE SUTURE WHICH CONNECTS PUSH CATHETER AND THE STENT WAS TORN. THE DEVICE WAS NOT USED DURING THE PROCEDURE. IT WAS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539210 11643365

    Patients

    Seq Age Sex Outcome Treatment
    1