BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 1581190 · Received January 14, 2010

    Report

    Report Number
    2953189-2010-00002
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 12, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PULMONARY EMBOLISM IS A RECOGNIZED COMPLICATION OF VENOUS ABLATION THERAPY THAT IS DESCRIBED IN THE PRODUCT INSTRUCTIONS-FOR-USE. IN ADDITION, OTHER PATIENT FACTORS COULD CONTRIBUTE TO THIS COMPLICATION SUCH AS THE PATIENT'S AGE, FAMILY HISTORY, OR THE PRESENCE OF OTHER MEDICAL PROBLEMS. AS SUGGESTED IN THE INSTRUCTIONS-FOR-USE UNDER FOLLOW-UP CARE, VNUS RECOMMENDS THE FOLLOWING: INSTRUCT PATIENT TO AMBULATE FREQUENTLY AND REFRAIN FROM STRENUOUS ACTIVITIES OR HEAVY LIFTING FOR SEVERAL DAYS. POST-OPERATIVE COMPRESSION FOR AT LEAST 1 WEEK IS RECOMMENDED. FOLLOW-UP EXAMINATION WITHIN 72 HOURS SHOULD INCLUDE AN ASSESSMENT TO ENSURE THAT THERE IS NO THROMBOSIS EXTENSION INTO THE DEEP VEINS.

    Description of Event or Problem · 1

    IN 2009, A FEMALE PATIENT UNDERWENT A VENOUS ABLATION PROCEDURE IN THE LEFT GREATER SAPHENOUS VEIN. THREE DAYS LATER, THE PATIENT COMPLAINED OF WEAKNESS AND SHORTNESS OF BREATH. A CARDIAC EVALUATION DID NOT FIND ANY SIGNIFICANT ABNORMALITIES. A CAT SCAN EVALUATION REVEALED A PULMONARY EMBOLISM. SHE WAS TREATED WITH ANTICOAGULANT MEDICATION (ACENOCOUMAROL). FOLLOW-UP WAS PERFORMED ONE DAY AFTER TREATMENT WITH ANTICOAGULANT MEDICATION, AND PATIENT WAS FEELING FINE WITH NO SHORTNESS OF BREATH.

    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 479082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R