BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIVEIN OC INFUSION CATHETER

    MDR report key: 7150569 · Received December 28, 2017

    Report

    Report Number
    3005831739-2017-00016
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 27, 2017
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLARIVEIN OC PRODUCT IS NOT MARKETED IN THE USA.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN WHICH THE CLARIVEIN OC INFUSION CATHETER WAS USED, PHYSICIAN REPORTED THAT WHILE NAVIGATING THE CATHETER THROUGH THE VASCULATURE, THE DISPERSION WIRE BECAME CAUGHT ON THE VESSEL TISSUE. WHILE ATTEMPTING TO REMOVE THE CATHETER, THE DISPERSION WIRE WAS FOUND TO BE BROKEN, RESULTING IN A 16 CM WIRE FRAGMENT, WHICH THE PHYSICIAN REMOVED USING A CLAMP VIA A 5CM INCISION UNDER LOCAL ANESTHETIC. THE PHYSICIAN NOTED THAT THE CATHETER ASSEMBLY PORTION OF THE CLARIVEIN DEVICE DID NOT LOCK INTO THE MDU PORTION OF THE DEVICE (MOTOR DRIVE UNIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930017 CLARIVEIN OC INFUSION CATHETER CLARIVEIN OC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC O-65-018-E4S SP65E140454535O

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention