BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENCLOSE EVSRF CATHETER

    MDR report key: 12921890 · Received December 2, 2021

    Report

    Report Number
    3011879048-2021-00023
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    September 1, 2021
    Report Date
    December 2, 2021
    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 · 0

    GENNADY VULAKH, RIANNA SEGAL, ANIL HINGORANI, NATALIE MARKS, ET AL. EARLY RESULTS WITH A NEW ENDOVENOUS RADIO-FREQUENCY ABLATION CATHETER. JOURNAL OF VASCULAR SURGERY 2021; 74, 3-E274. THE DEVICE LOT NUMBERS ARE UNKNOWN AND THE DEVICES WERE NOT RETURNED FOR EVALUATION. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR ANY TRENDS. IF MORE INFORMATION ARE PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A POSTER ARTICLE IN THE JOURNAL OF VASCULAR SURGERY, "EARLY RESULTS WITH A NEW ENDOVENOUS RADIO-FREQUENCY ABLATION CATHETER", NOTED 9 CASES (1.48%) OF ENDOVENOUS HEAT-INDUCED THROMBOSES (EHITS) WERE OBSERVED IN 606 PROCEDURES PERFORMED OVER AN 8-MONTH PERIOD ON 300 PATIENTS. IN THE 9 EHIT CASES, SEVEN WERE CLASS I, ONE WAS A CLASS 2 AND ONE WAS A CLASS 3. NO ADDITIONAL DATA WAS PROVIDED FOR THE EHITS. ADDITIONAL INFORMATION: GENDER: 211 FEMALE, 89 MALE. AGE: 18 - 91 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819388 VENCLOSE EVSRF CATHETER ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES GEI VENCLOSE, INC. VC-10A2.5-6F-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention