BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIVEIN

    MDR report key: 4963425 · Received July 30, 2015

    Report

    Report Number
    3005831739-2015-00004
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 14, 2015
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLARIVEIN OC IS NOT DISTRIBUTED IN THE USA. IT IS THE SAME PHYSICAL DESIGN AS THE CLARIVEIN IC WHICH IS COMMERCIALIZED IN THE USA PER 510K CLEARANCE. VASCULAR INSIGHTS IS REPORTING THIS POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT THE GREAT SAPHENOUS VEIN (GSV) WITH SCLEROSANT, UTILIZED THE CLARIVEIN OC TO DELVER THE PHYSICIAN-SPECIFIED SCLEROSING AGENT. THE PATIENT WAS REPORTED TO BE A MALE WITH A COMPLICATED VENOUS STRUCTURE AND INCLUDED ACTIVE ULCERATION. THE PHYSICIAN MADE THREE ACCESS POINTS. THE FIRST SECTION WAS TREATED WITHOUT INCIDENT TO THE PATIENT. THE PHYSICIAN USED A NEW A CATHETER DURING TREATMENT OF THE SECOND SECTION; AND UPON REMOVAL OF THE CATHETER WIPED TISSUE OFF THE WIRE TIP. THE PHYSICIAN PROCEEDED TO TREAT THE 7-8 CM THIRD SECTION OF THE LEG WITH THE SAME CATHETER. AT THE TIME OF THE DEVICE WITHDRAWAL IT WAS DISCOVERED THAT THE WIRE TIP WAS MISSING. X-RAY WAS UTILIZED TO LOCATE THE TIP FRAGMENT; AND IT WAS REMOVED VIA A 3CM INCISION OF THE GSV WITHOUT FURTHER INCIDENT. THE PATIENT WAS REPORTED AS DOING FINE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498376 CLARIVEIN INFUSION CATHETER KRA VASCULAR INSIGHTS LLC O-65-018-E4S SP65E140204786O

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention