BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM

    MDR report key: 1084115 · Received May 21, 2008

    Report

    Report Number
    3005099803-2008-00510
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    JCT
    PMA / PMN Number
    K012752
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNO BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. THE APRIL 2008 15-MONTH ULTRAFLEX TRACHEOBRONCHIAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM JCT JCT BOSTON SCIENTIFIC IRELAND, LTD. M00569060 0009727372

    Patients

    Seq Age Sex Outcome Treatment
    1