BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT

    MDR report key: 1133741 · Received August 20, 2008

    Report

    Report Number
    3005099803-2008-03091
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K023870
    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 A BILIARY STENTING TREATMENT PROCEDURE THE INNER SHEATH TORE. A 8.5FR/10CM FLEXIMA BILIARY STENT HAD BEEN ADVANCED OVER AN UNSPECIFIED GUIDEWIRE TO AN UNSPECIFIED BILIARY LOCATION. WHILE ATTEMPTING TO DEPLOY THE STENT, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE DEVICE APPEARED "STRETCHED" AND THE INNER SHEATH WAS "TORN". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT FGE BOSTON SCIENTIFIC M00539270 11625823

    Patients

    Seq Age Sex Outcome Treatment
    1