BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 4265287 · Received November 17, 2014

    Report

    Report Number
    3005831739-2014-00007
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 10, 2014
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THROMBUS EXTENSION INTO LEFT CFV; PATIENT TAKEN FOR IVC FILTER PLACEMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741054 CLARIVEIN CONTINUOUS FLASH CATHETER KRA VASCULAR INSIGHTS LLC 45-018-E2S ME451403014I

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR