BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 17914161 · Received October 11, 2023

    Report

    Report Number
    3010412492-2023-00004
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
    Product Code
    PLA
    PMA / PMN Number
    K172493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, THE CAUSE OF THE PATIENT'S BRADYCARDIA CANNOT BE CONCLUSIVELY DETERMINED. POTENTIAL FACTORS THAT COULD HAVE CONTRIBUTED TO OR CAUSED THIS PATIENT'S BRADYCARDIA INCLUDE: (1) GENERAL ANESTHETICS, (2) THE USE OF ANTIHYPERTENSIVE MEDICATION, (3) THE USE OF HIGH FREQUENCY LOW TIDAL VOLUME (HFLTV) VENTILATION, AND (4) HYPOTHERMIA. BASED ON THE TIMELINE OF THE EVENTS AND PATIENT TEMPERATURE DATA COLLECTED DURING THE PROCEDURE, IT WAS DETERMINED THE USE OF HFLTV VENTILATION WAS MOST LIKELY THE PRIMARY TRIGGER FOR THE PATIENT'S BRADYCARDIA. HOWEVER, IT COULD NOT BE CONCLUSIVELY DETERMINED THAT THE ENSOETM DID NOT CONTRIBUTE TO THE PATIENT'S BRADYCARDIA BY COOLING THE PATIENT DURING THE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE TO TREAT THEIR ATRIAL FIBRILLATION ON (B)(6) 2023. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AT 10:48AM ON (B)(6) 2023 WITH PROPOFOL AND SEVOFLURANE AND WAS INTUBATED WITH A STANDARD ENDOTRACHEAL TUBE. THE ENSOETM WAS PLACED WITHOUT DIFFICULTY SHORTLY AFTER 11:00AM, WITH NO EVIDENCE OF MALFUNCTION. FOLLOWING PLACEMENT OF THE ENSOETM, INTRAVASCULAR ACCESS WAS OBTAINED AT 3 SITES ON THE RIGHT FEMORAL VEIN, AND TRANSEPTAL ACCESS WAS SUCCESSFULLY PERFORMED. AT APPROXIMATELY 11:30AM, IN PREPARATION FOR LEFT ATRIAL MAPPING AND ABLATING, THE VENTILATION SETTINGS WERE CHANGED FROM STANDARD VENTILATION (12 BREATHS PER MINUTE WITH A TIDAL VOLUME OF 492ML) TO HIGH FREQUENCY LOW TIDAL VOLUME VENTILATION (26 BREATHS PER MINUTE WITH A TIDAL VOLUME OF 223ML). OVER THE NEXT 5 MINUTES, THE PATIENT'S CO2 LEVEL INCREASED, AND THE PATIENT'S HEART RATE DECREASED, FROM APPROXIMATELY 90 BEATS PER MINUTE TO BELOW 33 BEATS PER MINUTE, INDICATING BRADYCARDIA. IN RESPONSE, INTRACARDIAC PACING WAS INITIATED, AND 30 SECONDS OF COMPRESSIONS WERE GIVEN WHILE EPHEDRINE WAS GIVEN AND VENTILATION WAS REVERTED TO STANDARD SETTINGS, RESULTING IN RECOVERY OF THE PATIENT'S HEART RATE AND BLOOD PRESSURE. NO PERICARDIAL EFFUSION WAS SEEN ON INTRACARDIAC ECHOCARDIOGRAPHY. THE CASE WAS SUBSEQUENTLY CANCELLED, THE PATIENT WAS RECOVERED FROM ANESTHESIA, AND A BRAIN CT SCAN SHOWED NO EVIDENCE OF EMBOLIC EVENTS. THE PATIENT RECOVERED WITHOUT SEQUELAE, AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY THE NEXT DAY ((B)(6) 2023) WITHOUT THE USE OF HIGH FREQUENCY LOW TIDAL VOLUME VENTILATION AND WITHOUT THE USE OF ENSOETM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180969 ENSOETM ESOPHAGEAL THERMAL REGULATION DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD02-A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention CINCINNATI SUB-ZERO/GENTHERM BLANKETROL III