BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 4179883 · Received October 14, 2014

    Report

    Report Number
    3005831739-2014-00006
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 6, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THERE WERE NO ISSUES CITED WITH THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    POPLITEAL DVT AFTER SSV CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650266 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR