BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE CATHETER

    MDR report key: 376775 · Received February 13, 2002

    Report

    Report Number
    2953189-2002-00002
    Event Type
    Injury
    Date Received
    February 13, 2002
    Date of Event
    January 21, 2002
    Report Date
    February 13, 2002
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON THE 4TH DAY AFTER THE CLOSURE PROCEDURE, DURING THE ROUTINE FOLLOW-UP, A NON-OCCLUSIVE THROMBUS WAS DETECTED USING DUPLEX ULTRASOUND. THE THROMBUS WAS APPROX 3CM IN LENGTH AND EXTENDED INTO THE DEEP VEIN SYSTEM FROM THE SAPHENOFEMORAL JUNCTION. THE PT WAS ASYMPTOMATIC AND DID NOT SHOW ANY SIGNS OR COMPLICATIONS RELATED TO THE THROMBUS. THE PT WAS HOSPITALIZED ON THE SAME DAY AND PLACED ON LOW MOLECULAR WEIGHT HEPARINE (LOVENOX) AND COUMADIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE CATHETER INTRAVASCULAR CATHETER GEI VNUS MEDICAL TECHNOLOGIES, INC. CL-812-60 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization POLYDOCANOL INJECTIONS THROUGH THE SHEATH AT THE| END OF THE CLOSURE TREATMENT.