BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 6159260 · Received December 9, 2016

    Report

    Report Number
    3005831739-2016-00005
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 29, 2016
    Report Date
    December 6, 2016
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLARIVEIN DEVICE WAS NOT AVAILABLE FOR INVESTIGATION; AND NO LOT NUMBER WAS PROVIDED IN THE COMPLAINT REPORT; THEREFORE, NO LOT HISTORY OR COMPLAINT LOG REVIEW COULD BE PERFORMED. IF NICOLAU SYNDROME DID OCCUR, IT IS THE FIRST CASE REPORTED TO VASCULAR INSIGHTS MAY HAVE COME FROM A MISHANDLING OF THE SCLEROSANT OR FROM THE ADMINISTRATION OF THE LOCAL ANESTHETIC FOR SHEATH PLACEMENT. NICOLAU SYNDROME FROM LIDOCAINE DELIVERY IS REPORTED IN THE LITERATURE. IT IS ALSO RARELY BUT NOTED WITH SCLEROTHERAPY. ·THERE IS NO EVIDENCE OF A DIRECT CONNECTION BETWEEN THE CLARIVEIN DEVICE AND THE DEVELOPMENT OF NICOLAU SYNDROME; IN ANY CASE, THE PATIENTS WORSENING BILATERAL LEG EDEMA IS NOT RELATED TO THE CLARIVEIN CATHETER. HOWEVER VI IS CONSERVATIVELY NOTIFYING THE FDA OF THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. DEVICE NOT MADE AVAILABLE BY PHYSICIAN.

    Description of Event or Problem · 1

    DR. (B)(6), REPORTED NICOLAU SYNDROME AFTER A PROCEDURE WHERE CLARIVEIN WAS USED TO DELIVER SOTRADECOL. THERE WERE NO ISSUES CITED WITH USE OF THE CLARIVEIN DEVICE DURING THE PROCEDURE. SUPPLIED WRITTEN INFORMATION DID NOT INDICATE NICOLAU. THE PATIENT'S SYMPTOMS BEFORE TREATMENT WERE BILATERAL SEVERE LEG EDEMA AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808825 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR