BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARIVEIN CATHETER

    MDR report key: 2614348 · Received June 5, 2012

    Report

    Report Number
    3005831739-2012-00001
    Event Type
    Other
    Date Received
    June 5, 2012
    Date of Event
    May 14, 2012
    Report Date
    June 5, 2012
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DVT IS A KNOWN POTENTIAL ADVERSE EFFECT IN INTERVENTIONAL PROCEDURES. THIS IS NOT A DEVICE FAILURE. THE PHYSICIAN TREATED THE DVT WITH LEVONOX AND COUMADIN AND THE TARGET PROCEDURE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    PREVIOUSLY TREATED GSV WAS TREATED BELOW THE KNEE. DVT AT POSTERIOR TIBIAL POPLITEAL JUNCTION. PT WAS TREATED WITH LOVENOX AND COUMADIN AND TARGET PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIVEIN CATHETER INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 45-018-E2S ME451402811I

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention