BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT

    MDR report key: 1082671 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01243
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    JCT
    PMA / PMN Number
    K963241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRACHEOBRONCHIAL STENTING TREATMENT PROCEDURE, THE STENT FAILED TO DEPLOY. A UPC/12-3/16/95, 1.5CM COVER - DISTAL ULTRAFLEX TRACHEOBRONCHIAL STENT HAD BEEN ADVANCED TO TREAT AN UNSPECIFIED LUNG STRICTURE. THE PHYSICIAN WAS UNABLE TO DEPLOY THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT JCT BOSTON SCIENTIFIC M00569060 9727372

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR