BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 3961606 · Received June 16, 2014

    Report

    Report Number
    3005831739-2014-00003
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 3, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC.
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS FOUND TO HAVE A THROMBUS IN HER RIGHT LOWER LEG. PATIENT WAS ASYMPTOMATIC. THE COMMON FEMORAL VEIN WAS WIDELY PATENT. PATIENT WAS TREATED WITH LOVENOX AND THE THROMBUS WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353270 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening