BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN INFUSION CATHETER

    MDR report key: 1655792 · Received April 7, 2010

    Report

    Report Number
    3005831739-2010-00002
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 29, 2010
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHYSICIAN STATED THAT THE DEVICE DID NOT MALFUNCTION AND CONFIRMED THAT THE DEVICE WORKED PROPERLY DURING SURGERY. THIS INCIDENT WAS BELIEVED TO BE THE RESULT OF HOW THE SURGERY WAS CARRIED OUT. LACK OF POST PROCEDURE AMBULATION AND THE SUBSEQUENT TREATMENT OF THE GSV IN THE SAME LEG ON THE SAME DAY MAY HAVE CONTRIBUTED TO THE THROMBOSIS FORMATION. PATIENT WAS ALSO NOTED TO HAVE AN APPROXIMATE 3MM VEIN PRE SURGERY. A VEIN OF THIS SIZE WOULD BE A SMALL FACTOR, IF ANY, CONTRIBUTING TO THE PATIENT'S SYMPTOMS. THE PATIENT IS DOING WELL AND CONTINUES TO BE ASYMPTOMATIC. ADDITIONALLY, DVT IS A KNOWN SIDE EFFECT FOR THESE TYPES OF SURGICAL PROCEDURES.

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED DURING A VENOUS ABLATION PROCEDURE ON THE LEFT SHORT SAPHENOUS VEIN. AT FOUR DAYS POST PROCEDURE ((B) (4) 2010), A VENOUS DUPLEX ULTRASOUND SHOWED A LEFT POPLITEAL DVT. PATIENT WAS ASYMPTOMATIC AND WAS PRESCRIBED LOVENOX AND COUMADIN. ON (B) (6) 2010, A DUPLEX ULTRASOUND SHOWED NO FURTHER PROPAGATION OF DVT AND THE PATIENT REMAINS ASYMPTOMATIC. THE VEIN WAS SUCCESSFULLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIVEIN INFUSION CATHETER INFUSION CATHETER KRA VASCULAR INSIGHTS LLC VC01-01-047-01 ME451400310J

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other