BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 4346648 · Received December 16, 2014

    Report

    Report Number
    3005831739-2014-00008
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 19, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS TREATED FOR SUPERFICIAL VENOUS INSUFFICIENCY IN BOTH THE RIGHT AND LEFT GREAT SAPHENOUS VEINS USING A CLARIVEIN CATHETER. FOLLOWING THE PROCEDURE THERE WAS A NON-OCCLUSIVE THROMBUS FORMATION EXTENDING INTO THE RIGHT AND LEFT COMMON FEMORAL VEIN AT THE RIGHT AND LEFT SAPHENO-FEMORAL JUNCTIONS. THE PT WAS TREATED WITH ANTICOAGULANTS; THE LEFT AND RIGHT VEIN THROMBUS WAS FOUND TO RESOLVE IN ONE AND TWO DAYS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821914 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S NA

    Patients

    Seq Age Sex Outcome Treatment
    1