BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSURE FAST CATHETER

    MDR report key: 1150521 · Received September 4, 2008

    Report

    Report Number
    2953189-2008-00010
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 5, 2008
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTI-COAGULANT FOLLOWING THE DISCOVERY OF A PULMONARY EMBOLISM. AT THE LAST FOLLOW UP VISIT IN 2008, THE PATIENT'S CONDITION WAS SATISFACTORY. THE CLOSUREFAST CATHETER WAS DISCARDED AFTER THE PROCEDURE, THEREFORE AN INVESTIGATION OF THE DEVICE CANNOT BE PERFORMED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS TREATED FOR A RIGHT GREATER SAPHENOUS VEIN CLOSURE. THERE WERE NO ABNORMALITIES NOTED BEFORE, DURING OR AFTER THE PROCEDURE BY THE ATTENDING PHYSICIAN. AT APPROX 9 DAYS LATER, DURING A ROUTINE FOLLOW UP APPOINTMENT, A CT SCAN WAS CONDUCTED AND FOUND A PE (PULMONARY EMBOLISM). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN AN ANTI-COAGULANT AND DISCHARGED. ON A FOLLOW-UP OCCURRED ABOUT 2 DAYS LATER, AND THE PATIENT'S CONDITION WAS SATISFACTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention VNUS RFGPLUS GENERATOR