BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 7125418 · Received December 18, 2017

    Report

    Report Number
    3005831739-2017-00015
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 18, 2017
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    UDI-DI
    10854339004027
    PMA / PMN Number
    K071468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CLARIVEIN CATHETER DISPERSION WIRE TIP GOT CAUGHT INSIDE THE VEIN. AFTER THE TIP WAS FREED, THE DEVICE WAS RE-ACTIVATED BUT AFTER APPROXIMATELY 5 SECONDS IT WAS VERIFIED USING ULTRASOUND NOT TO BE SPINNING. THE SHEATH WAS REMOVED WITH AN ATTEMPT TO REMOVE THE WIRE BUT ULTRASOUND SHOWED A WIRE FRAGMENT REMAINED IN THE VEIN. DR. (B)(6) PERFORMED A 1 CM CUT, AND HOOK, AND PULLED OUT THE BROKEN WIRE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906184 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S BM651403816I 10854339004027

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention