BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE CATHETER

    MDR report key: 372533 · Received January 16, 2002

    Report

    Report Number
    2953189-2002-00001
    Event Type
    Injury
    Date Received
    January 16, 2002
    Date of Event
    December 4, 2001
    Report Date
    December 18, 2001
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE ONE WEEK FOLLOW-UP EXAM, PATIENT PRESENTED WITH SIGNIFICANT SWELLING IN TREATED LEG. ULTRASOUND SCAN REVEALED AN OCCLUSIVE DVT EXTENDING FROM COMMON FEMORAL VEIN TO INFERIOR VENA CAVA. PATIENT WAS HOSPITALIZED FOR AN UNSPECIFIED LENGTH OF TIME, AND RECEIVED TPA THROMBOLYSIS. PATIENT ALSO RECEIVED ILIAC VEIN STENT PLACEMENT FOR PREVIOUSLY UNDETECTED ILIAC VEIN OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE CATHETER INTRAVASCULAR CATHETER DQO VNUS MEDICAL TECHNOLOGIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R