BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN CATHETER

    MDR report key: 2858911 · Received November 13, 2012

    Report

    Report Number
    3005831739-2012-00003
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 12, 2012
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PRESENTED WITH PE POST VEIN PROCEDURE. ULTRASOUND REPORT NEGATIVE FOR ACUTE OR CHRONIC DVT. PT TREATED WITH COUMADIN AND LOVENOX AND ASKED TO FOLLOW UP FOR PREVENTATIVE CARE. CLINICAL REPORT ON FILE AT SITE.

    Description of Event or Problem · 1

    PT WAS DIAGNOSED TO PRESENT A PULMONARY EMBOLISM IN THE LEFT LOWER EXTREMITY POST VEIN PROCEDURE. POST PROCEDURE INVESTIGATION WITH GRAY SCALE COLOR FLOW COMPRESSION. ULTRASOUND WAS PERFORMED OF THE BILATERAL LOWER EXTREMITIES AND SHOWED NORMAL COLOR FLOW, COMPRESSIBILITY AND RESPIRATORY VARIATION. NO INTRALUMINAL ECHOGENIC MATERIALS IS SEEN TO SUGGEST THROMBUS. PULMONARY EMBOLISM REPORTED FROM (B)(6). SUPERFICIAL VEIN THROMBOSIS, SWELLING, POST PROCEDURE. ULTRASOUND TO INTERROGATE THE DEEP SUPERFICIAL VEINS OF THE LEFT LOWER EXTREMITY. NO EVIDENCE OF DVT IN THE BILATERAL FEMORAL-POPLITEAL VENOUS SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIVEIN CATHETER CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S ME651402912I

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention