BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 1580444 · Received January 13, 2010

    Report

    Report Number
    2953189-2010-00001
    Event Type
    Death
    Date Received
    January 13, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 13, 2010
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PULMONARY EMBOLISM IS A RECOGNIZED COMPLICATION OF VENOUS ABLATION PROCEDURES AND MAY BE CAUSED BY A NUMBER OF FACTORS INCLUDING THE PT'S AGE, IMMOBILITY, AND FAMILY HISTORY. THERE IS NOTHING TO INDICATE THAT THIS INCIDENT IS THE RESULT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IN 2009, A FEMALE PT UNDERWENT A VENOUS ABLATION PROCEDURE. PHYSICIAN REPORTED THAT THE PROCEDURE OCCURRED WITHOUT INCIDENT AND NO COMPLICATIONS OR PRODUCT PROBLEMS WERE EXPERIENCED. THE FOLLOWING DAY, PT TOLD FAMILY MEMBERS THAT SHE WAS NOT FEELING WELL. SHE IGNORED THEIR ADVICE TO SEEK MEDICAL ATTENTION OR TO CALL THE PHYSICIAN. PT LATER EXPERIENCED CARDIAC ARREST AT HOME AND WAS TRANSPORTED TO AN ER FOR EMERGENCY TREATMENT. CAT SCAN REVEALED BILATERAL PULMONARY EMBOLI AND BRAIN EDEMA. HYPOTHERMIA PROTOCOL AND THROMBOLYTICS WERE ADMINISTERED. FOUR DAYS LATER, PT WAS PRONOUNCED BRAIN DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST CATHETER ELECTROSURGICAL CUTTING AND COAGULATION GEI VNUS MEDICAL TECHNOLOGIES, INC. CF7-7-60

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death