BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    MDR report key: 8066620 · Received November 13, 2018

    Report

    Report Number
    3011706110-2018-00218
    Event Type
    Death
    Date Received
    November 13, 2018
    Report Date
    November 23, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K082203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE STATED IN ORIGINAL NARRATIVE THE PRODUCT CODE #/ DEVICE NAME WAS INCORRECT. THE COMPLAINT IS AGAINST THE DEVICE NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX, PRODUCT NUMBER CSK-023 ¿ 510K NUMBER - K082203. INFORMATION WAS LIMITED AND THROUGH RESEARCH, THIS INFORMATION ONLY JUST CAME TO LIGHT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER WAS NOT REPORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION. MULTIPLE ATTEMPTS HAVE BEEN MADE UNSUCCESSFULLY BY ATRICURE TO OBTAIN FOLLOW-UP INFORMATION FROM THE SURGEON SUCH AS DATE OF OCCURRENCE AND DETAILED PROCEDURE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON ON (B)(6) 2018, DURING A CONFERENCE IN MILAN, "THE CONVERGENT APPROACH COMBINING FORCES FOR PERSISTENT AF: NOVEL APPROACH IN HYBRID TERMS" EARLY ON CONVERGENT CASES WHILE USING EPI-SENSE DEVICE ONE OF HIS PATIENTS HAD EXPERIENCED AN ATRIO-ESOPHAGEAL FISTULA AND LATER, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903330 NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE, INC. CSK-023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death