BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSUREFAST CATHETER

    MDR report key: 1298730 · Received January 26, 2009

    Report

    Report Number
    2953189-2009-00002
    Event Type
    Injury
    Date Received
    January 26, 2009
    Date of Event
    August 28, 2008
    Report Date
    January 26, 2009
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. STATED THAT THE CASE WAS COMPLETED WITH NOTHING ABNORMAL NOTED BEFORE, DURING OR IMMEDIATELY AFTER TREATMENT. DURING A PATIENT FOLLOW UP DATED, 2008, THE PATIENT'S CONDITION HAD IMPROVED. PULMONARY EMBOLISM IS A RECOGNIZED COMPLICATION OF ENDOVENOUS ABLATION AND IS ADDRESSED IN THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS TREATED FOR A RIGHT GREATER SAPHENOUS VEIN CLOSURE. SEVEN DAYS AFTER THE SURGERY THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED FOR PULMONARY EMBOLISM (PE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNUS CLOSUREFAST CATHETER ELECTROSURGICAL CUTTING AND COAGULATION GEI VNUS MEDICAL TECHNOLOGIES, INC. CF7-7-

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization FOLLOW UP DATES: