BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE CATHETER

    MDR report key: 535635 · Received July 21, 2004

    Report

    Report Number
    2953189-2004-00002
    Event Type
    Injury
    Date Received
    July 21, 2004
    Date of Event
    November 8, 2003
    Report Date
    July 19, 2004
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW-UP 5 DAYS AFTER THE CLOSURE PROCEDURE, A NON-OCCLUSIVE THROMBUS EXTENSIVE FROM THE OCCLUSIVE GSV THROMBUS WAS DETECTED IN THE CFR. THE PT SUFFERED A MILD PAIN. THE PT WAS NOT HOSPITALIZED AND WAS PLACED ON LOVENOX FOR UNSPECIFIED PERIOD OF TIME. AT TIME OF FOLLOW-UP IN 2004, THE PT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE CATHETER INTRAVASCULAR CATHETER GEI VNUS MEDICAL TECHNOLOGIES, INC. CL-625-60 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention