BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN

    MDR report key: 5386159 · Received January 22, 2016

    Report

    Report Number
    3005831739-2015-00006
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    November 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PERFORMED AS DESIGNED WITH NO MALFUNCTION. DEVICE NOT MADE AVAILABLE BY PHYSICIAN.

    Description of Event or Problem · 1

    PATIENT HAD REFLUX IN THE LEFT AND RIGHT GSV CONFIRMED BY ULTRASOUND. ON (B)(6) 2015 THE PHYSICIAN USED THE CLARIVEIN IC INFUSION CATHETER TO INFUSE PHYSICIAN SPECIFIED MEDICATION TO THE PERIPHERAL VASCULAR. THE LEFT GSV, PROXIMAL AND DISTAL, WAS TREATED WITH A SCLEROSING AGENT IN 2 SEGMENTS DUE TO THE LENGTH OF THE VEIN. ON (B)(6) 2015 THE RIGHT GSV, PROXIMAL AND DISTAL, WAS TREATED IN 2 SEGMENTS DUE TO THE LENGTH OF THE VEIN. THREE DAYS POST PROCEDURE ULTRASOUND CONFIRMED NO COMPLICATIONS AND BOTH GSV'S CLOSED. ON (B)(6) 2015 DVT WAS IDENTIFIED IN THE LEFT POPLITEAL VEIN, THE LEFT FEMORAL VEIN MID DISTAL AND LEFT GASTROCNEMIUS VEIN; THE TREATED VEINS REMAINED CLOSED PER ULTRASOUND. ON (B)(6) 2015 COMPLICATED BY DEVELOPMENT OF LEFT LOWER EXTREMITY DVT AND BILATERAL PULMONARY EMBOLI, AN IVC FILTER WAS PLACED AND CATHETER DIRECTED VENOUS THROMBOLYSIS WITH TPA WAS PRESCRIBED. ON (B)(6) 2015 ASPIRATION THROMBECTOMY OF THE SUPERFICIAL FEMORAL AND PROXIMAL POPLITEAL VEINS WAS PERFORMED; THE THROMBOLYSIS PROCEDURE WAS TERMINATED AND FILTER REMOVED; INTRAVENOUS HEPARIN ANTICOAGULATION THERAPY WAS RESUMED. THE PATIENT IS LAST REPORTED ON (B)(6) 2015 AS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43936 CLARIVEIN CONTINUOUS FLUSH CATHETER KRA VASCULAR INSIGHTS LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization