BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 16401097 · Received February 17, 2023

    Report

    Report Number
    3010412492-2023-00002
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
    Product Code
    PLA
    UDI-DI
    00857915006180
    PMA / PMN Number
    K172493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHED EVALUATION SUMMARY INCLUDES A DHR REVIEW AND CLINICAL ASSESSMENT. BASED ON THE PROVIDED INFORMATION, THE ENSOETM LIKELY CONTRIBUTED TO THE PATIENT'S HYPOTHERMIA. HOWEVER, A NUMBER OF OTHER FACTORS ALSO LIKELY SIGNIFICANTLY CONTRIBUTED TO THE PATIENT'S HYPOTHERMIA, INCLUDING: THE PATIENT'S EXISTING HYPOTHYROIDISM, THE USE OF A BETA-BLOCKER, THE USE OF AMIODARONE, A LOW STARTING TEMPERATURE, AND A DECREASED INTENSITY OF MONITORING PATIENT BODY TEMPERATURE DURING THE CASE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION AND ATRIAL FLUTTER ON (B)(6) 2023, AND THE ENSOETM WAS USED TO COOL THE ESOPHAGUS DURING THE PROCEDURE. THE PATIENT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE AT APPROXIMATELY 7:58AM LOCAL TIME, AND THE ENSOETM WAS PLACED AT APPROXIMATELY 8:27AM. AT APPROXIMATELY 11:00AM, TOWARDS THE END OF THE CASE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE HAD DECREASED FROM A SYSTOLIC PRESSURE ABOVE 80MMHG TO A SYSTOLIC PRESSURE BELOW 60MMHG. IMAGING ON INTRACARDIAC ECHOCARDIOGRAPHY SHOWED DECREASED VENTRICULAR CONTRACTILITY, PROMPTING THE ADMINISTRATION OF APPROXIMATELY 45 SECONDS OF CARDIOPULMONARY RESUSCITATION, ALONG WITH THE ADMINISTRATION OF AN EPINEPHRINE DRIP. THE PATIENT'S VITAL SIGNS IMPROVED, AND SHE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE A FOLEY CATHETER WITH TEMPERATURE MONITORING CAPABILITY WAS PLACED, SHOWING A TEMPERATURE OF 31°C. UPON REVIEW OF ANESTHESIA RECORDS, IT WAS DISCOVERED THE PATIENT REACHED A MINIMUM TEMPERATURE OF 29°C. HOWEVER, THE SOURCE OF THIS TEMPERATURE MEASUREMENT (WHETHER FROM NASOPHARYNGEAL, FOREHEAD, AXILLARY, ETC.) WAS NOT RECORDED, AND THE MINIMUM TEMPERATURE WAS NOT NOTICED OR REPORTED TO THE OPERATING TEAM. THE PATIENT WAS SUCCESSFULLY EXTUBATED 3 TO 4 HOURS AFTERWARDS AND ALL VASOPRESSORS WERE STOPPED, INDICATING CONTINUED RAPID IMPROVEMENT. AFTER STAYING OVERNIGHT IN THE INTENSIVE CARE UNIT, THE PATIENT WAS TRANSFERRED TO A STANDARD HOSPITAL ROOM AND THEN DISCHARGED THE FOLLOWING DAY IN GOOD CONDITION. THE PATIENT FULLY RECOVERED AND HAD NO FURTHER COMPLICATIONS OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656737 ENSOETM ESOPHAGEAL THERMAL REGULATION DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD02-A 199118722 00857915006180

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H CINCINNATI SUB-ZERO SUB-ZERO BLANKETROL III