BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 4009714 · Received July 3, 2014

    Report

    Report Number
    3005831739-2014-00002
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 16, 2014
    Manufacturer
    VASCULAR INSIGHTS, LLC.
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DVT WAS NOTED. IT WAS NON OCCLUSIVE AND SMALL BUT THE PATIENT BECAME SYMPTOMATIC WITH CHEST PAIN AND A BILATERAL PE WAS VISIBLE ON CT. IT WAS NOTED THAT THERE WERE NO ISSUES CITED WITH THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    PULMONARY EMBOLISM NOTED ON CT ON (B)(6) 2014. ON (B)(6) 2014, ULTRASOUND NOTED A GSV CLOT EXTENSION INTO CPV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392210 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention