BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

    MDR report key: 7110247 · Received December 12, 2017

    Report

    Report Number
    3011706110-2017-00104
    Event Type
    Death
    Date Received
    December 12, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K142084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THIS ADVERSE EVENT OCCURRED POST-OPERATION. NO PRODUCT HISTORY REVIEW WAS ABLE TO BE PERFORMED AS NO LOT NUMBER WAS REPORTED FOR THIS DEVICE. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE INITIAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) MALE PATIENT RECEIVED AN OFF-PUMP CONVERGENT EPICARDIAL/ENDOCARDIAL ABLATION PROCEDURE USING AN EPISENSE GUIDED COAGULATION SYSTEM (CDK-1413) AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT PRESENTED TO THE ER WITH SHORTNESS OF BREATH, PERIPHERAL EDEMA AND CHEST PAIN. THE PATIENT¿S CHEST X-RAY WAS CLEAR WITH NO PLEURAL EFFUSION. HOWEVER, A CT SCAN PERFORMED REVEALED SMALL LEFT AND TRACE RIGHT PLEURAL EFFUSION, WITH SMALL PERICARDIAL EFFUSION. THE PATIENT WAS PLACED UNDER OBSERVATION, TREATED WITH AN IV DIURETIC AND DISCHARGED WITH MAJOR IMPROVEMENT IN CONDITION. ON (B)(6) 2017, AN ECHO PERFORMED ON THE PATIENT SHOWED NO PERICARDIAL OR PLEURAL EFFUSION. ON (B)(6) 2017, THE PATIENT RETURNED TO HIS PRIMARY CARE PHYSICIAN WHO REPORTED AN EF 55%, AND THE PATIENT WAS DIRECTED TO CONSULT WITH THE CARDIAC SURGEON ON ADMINISTRATION OF MEDICINE. THE DIURETIC WAS INCREASED TO 80MG FOR THE DAY, AND THEN RETURNED TO 40MG/DAY. ON (B)(6) 2017, THE PATIENT RETURNED TO THE ER PRESENTING WITH AFIB AND CHF EXACERBATION. HIS WHITE CELL BLOOD COUNT WAS 19.7 AND CHEST X-RAY INDICATED HIS LUNGS WERE CLEAR AND UNREMARKABLE. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. ON (B)(6) 2017, WHILE BEING PREPARED FOR CARDIOVERSION, THE PATIENT STOPPED BREATHING, LOST PULSE, AND WAS UNRESPONSIVE. AFTER UNSUCCESSFUL ATTEMPTS AT REVIVING, THE PATIENT PASSED AWAY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887535 EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE, INC. CDK-1413

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death