BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVSRF CATHETER

    MDR report key: 9418928 · Received December 5, 2019

    Report

    Report Number
    3011879048-2019-00004
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    December 5, 2019
    Manufacturer
    VENCLOSE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K160754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR ANY TRENDS. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POSTER ARTICLE, "VENCLOSE VERSUS CLOSUREFAST: COMPARATIVE ANALYSIS OF EFFICACY, SHORT-TERM OUTCOMES, AND PROCEDURE TIME", THAT ON POST-PROCEDURE DUPLEX, A PATIENT HAD THROMBUS 1 MM AWAY FROM THE SFJ ON POST-PROCEDURE DUPLEX, BUT PATENT SUPERFICIAL EPIGASTRIC VEIN (KABNICK CLASS 1 AND LAWRENCE LEVEL I EHIT). THE PATIENT WAS TREATED WITH THERAPEUTIC ELIQUIS AND REPEAT DUPLEX 3 WEEKS LATER SHOWED RESOLUTION OF EHIT WITH THROMBUS 1.80 CM AWAY FROM THE SFJ. THE EHIT WAS STATED AS "CLINICALLY INSIGNIFICANT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215002 EVSRF CATHETER ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES GEI VENCLOSE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention