BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRACT ASPIRATION CATHETER

    MDR report key: 1895409 · Received November 4, 2010

    Report

    Report Number
    3005522028-2010-00004
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Product Code
    DXE
    PMA / PMN Number
    K053372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN SHARED THIS INFORMATION TO THE DIRECTOR OF CLINICAL AFFAIRS AND EDUCATION DURING A VISIT BETWEEN (B)(4) 2010. THE ADVERSE EVENT OCCURRED BEFORE THIS TIME FRAME.

    Description of Event or Problem · 1

    PHYSICIAN STATED THE TIP OF THE XTRACT CATHETER CREATED A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRACT ASPIRATION CATHETER DXE LUMEN BIOMEDICAL, INC. 1451-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention