BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE CATHETER

    MDR report key: 381009 · Received March 8, 2002

    Report

    Report Number
    2953189-2002-00004
    Event Type
    Injury
    Date Received
    March 8, 2002
    Date of Event
    February 8, 2002
    Report Date
    March 7, 2002
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON THE 3RD DAY AFTER THE CLOSURE PROCEDURE, DURING THE ROUTINE FOLLOW-UP, A NON-OCCLUSIVE THROMBUS WAS DETECTED USING DUPLEX ULTRASOUND, THE THROMBUS WAS APPROXIMATELY 2-3 CM IN LENGTH ALONG ONE WALL OF THE FEMORAL VEIN. THE PT WAS ASYMPTOMATIC AND DID NOT SHOW ANY SIGNS OR COMPLICATIONS RELATED TO THE THROMBUS. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS IMMEDIATELY PLACED ON LOW MOLECULAR WEIGHT HEPARIN (LEVONEX) AND COUMADIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE CATHETER INTRAVASCULAR CATHETER DQO VNUS MEDICAL TECHNOLOGIES, INC. 8 FRENCH (EXACT MODEL # IS UNKNOWN) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention