BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPI-SENSE GUIDED COAGULATION SYSTEM

    MDR report key: 20295511 · Received September 24, 2024

    Report

    Report Number
    3011706110-2024-00055
    Event Type
    Death
    Date Received
    September 24, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCM
    PMA / PMN Number
    P200002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CONVERGENT PROCEDURE VIA SUBXIPHOID APPROACH USING AN EPIST DEVICE. CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION WITH ATRICLIP DEVICE VIA LEFT VATS APPROACH WAS ALSO PERFORMED. FIVE HOURS POST PROCEDURE, THE PATIENT WAS NOTED TO HAVE DROOPING OF ONE SIDE OF HER FACE, WHICH PROGRESSED TO THE PATIENT BECOMING COMATOSE. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED EVIDENCE OF AN EMBOLIC STROKE, SHOWING OCCLUSION OF RIGHT CAROTID ARTERY AND A THROMBUS OCCLUDING THE LEFT CAROTID ARTERY. THE THROMBUS WAS REMOVED FROM THE LEFT CAROTID ARTERY, BUT THE OCCLUSION IN THE RIGHT CAROTID ARTERY WAS UNABLE TO BE ADDRESSED. ON FURTHER EVALUATION, PATIENT¿S FEMORAL ARTERIES WERE FOUND TO BE OBSTRUCTED BILATERALLY, WITH ABSENCE OF BILATERAL DISTAL PULSES. THE PATIENT¿S CONDITION CONTINUED TO DETERIORATE, AND ON THE FOURTH POST OPERATIVE DAY, THE PATIENT EXPIRED. WHILE ATRICURE CANNOT CONFIRM THAT DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT¿S COMPLICATION OR DEMISE, WE ARE REPORTING PER 21 CFR PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291415 EPI-SENSE GUIDED COAGULATION SYSTEM SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING OCM ATRICURE, INC. EPIST UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death