BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 6722200 · Received July 18, 2017

    Report

    Report Number
    3005831739-2017-00009
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    June 11, 2017
    Report Date
    July 18, 2017
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLARIVEIN DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THERE WERE NO ISSUES CITED WITH DEVICE PERFORMANCE. VI REQUESTED THE PROCEDURAL REPORTS AND ULTRASONIC IMAGES BUT THEY WERE NOT PROVIDED FOR REVIEW. POTENTIAL ADVERSE EFFECTS THAT MIGHT BE ASSOCIATED WITH THE CLARIVEIN® DEVICE ARE SIMILAR TO THOSE ASSOCIATED WITH ANY INTERVENTIONAL VASCULAR PROCEDURE. THE IFU PROVIDED WITH THE CLARIVEIN DEVICE LISTS THE POTENTIAL ADVERSE EVENTS THAT MIGHT BE ENCOUNTERED DURING A PERIPHERAL VASCULATURE INFUSION PROCEDURE USING THE CLARIVEIN® IC AS WELL AS INSTRUCTS THE USER TO CONSULT LABELING OF AGENTS TO BE DELIVERED PRIOR TO INFUSION.

    Description of Event or Problem · 1

    PHYSICIAN USED CLARIVEIN TO DELIVER ASCLERA (POLIDOCANOL) 20MG/2ML TO A PATIENT ON FOLLOW UP THE PATIENT WAS NOTED TO HAVE A THROMBUS EXTENSION (TYPE 1) AT THE SAPHENOUS-FEMORAL JUNCTION (SFJ) POST PROCEDURE. ON SECOND FOLLOW UP IT WAS ALSO NOTED THAT A DVT HAD DEVELOPED IN THE CFV (COMMON FEMORAL VEIN) DISTAL TO THE SFJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502008 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 85-018-E140S BM85E140S2816I

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR