BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 3842761 · Received May 16, 2014

    Report

    Report Number
    3005831739-2014-00001
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 13, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DVT IS A KNOWN POTENTIAL ADVERSE EVENT IN INTERVENTIONAL PROCEDURES AND IS NOT RELATED TO A DEVICE FAILURE. DR. (B)(6) STATED THAT THERE WAS NO FAILURE OR MALFUNCTION OF THE CLARIVEIN DEVICE.

    Description of Event or Problem · 1

    DVT IN COMMON FEMORAL VEIN NOTED IN ON (B)(6) 2014 F/U VISIT. DR. (B)(6) STATED THAT THERE WAS NO FAILURE OR MALFUNCTION OF THE CLARIVEIN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293145 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention