BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 4122353 · Received September 18, 2014

    Report

    Report Number
    3005831739-2014-00005
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 19, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    A PROCEDURE WAS SUCCESSFULLY COMPLETED IN THE PROXIMAL RIGHT GSV USING THE CLARIVEIN DEVICE. ON THE ROUTINE FOLLOW UP ((B)(6) 2014) THE PATIENT PRESENTED WITH A DVT IN THE COMMON FEMORAL VEIN. THE PATIENT WAS TREATED WITH XARELTO. ULTRASOUND EXAMINATION ALSO REVEALED THE PRESENCE OF BAKER'S CYSTS IN THE RIGHT POPLITEAL FOSSA. BAKER'S CYST IS KNOWN TO COMPRESS THE POPLITEAL VEIN AND TO CAUSE DVTS. ON (B)(6) 2014 THE PATIENT PRESENTED WITH A DVT IN THE RIGHT POPLITERAL VEIN AS WELL AS THE "SUPERFICIAL FEMORAL VEIN". THE PATIENT HAD A G.I. BLEED AND SOME HEMATURIA NAD WAS TAKEN OFF OF ANTICOAGULATION. A VENA CAVA FILTER WAS PLACED. THERE WAS NO DEVICE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579276 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1