BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 16260226 · Received January 27, 2023

    Report

    Report Number
    3010412492-2023-00001
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    December 19, 2022
    Report Date
    January 27, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GIVEN THE BROAD RANGE OF ETIOLOGIES POTENTIALLY CAUSING ESOPHAGEAL HEMATOMAS, IT IS IMPOSSIBLE TO DEFINITIVELY DETERMINE THE EXACT CAUSE OF THIS PATIENT'S INJURY WITH THE PROVIDED INFORMATION. WHILE IT IS UNLIKELY THE ENSOETM CAUSED OR CONTRIBUTED TO THE INJURY FOUND IN THIS PATIENT, THE POSSIBILITY THAT ABRASIVE TRAUMA CAUSED BY THE ENSOETM MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY CANNOT BE RULED OUT.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2022 THAT UTILIZED THE ENSOETM TO COOL THE ESOPHAGUS DURING THE PROCEDURE. PRIOR TO THE PROCEDURE, AN ENDOTRACHEAL TUBE WAS USED TO SECURE THE PATIENT'S AIRWAY, AND PLACEMENT OF THE ENDOTRACHEAL TUBE INTO THE TRACHEA WAS NOTED TO BE DIFFICULT. THE INITIAL ATTEMPT AT PLACEMENT OF THE ENDOTRACHEAL TUBE MET RESISTANCE AND WAS STOPPED. MULTIPLE OPERATORS (INCLUDING A STUDENT CRNA, CRNA, AND ANESTHESIOLOGIST) ATTEMPTED PLACEMENT, AND MULTIPLE ATTEMPTS WERE REQUIRED. ANESTHESIA NOTES STATED THAT DIRECT LARYNGOSCOPY OFFERED ONLY A GRADE 3 VIEW IN THE CORMACK-LEHANE CLASSIFICATION (WHERE GRADING RANGES FROM I TO 4 WITH INCREASING DIFFICULTY OF VIEW OF THE GLOTTIS). ONCE ENDOTRACHEAL TUBE PLACEMENT WAS SUCCESSFUL, THE ENSOETM (OUR DEVICE) WAS INSERTED WITHOUT DIFFICULTY INTO THE ESOPHAGUS. THE PATIENT WAS IN THE PROCEDURE ROOM BY 11:21AM LOCAL TIME, THE ENSOETM WAS PLACED AROUND 11:45AM IN THE ESOPHAGUS, ACCESS WAS OBTAINED AT 12:05PM, CASE COMPLETION WAS AT 2:04PM, PATIENT EXTUBATION WAS AT 2:13PM, AND THE PATIENT WAS OUT OF THE ROOM BY 2:29PM. POST-OPERATIVELY, THE PATIENT NOTED 10/10 PERIUMBILICAL PAIN REQUIRING IV OPIATES AND REMAINED IN THE HOSPITAL FOR TWO NIGHTS. THE PAIN RESOLVED OVER A FEW DAYS. ON (B)(6) 2022, THE PATIENT NOTED DIFFICULTY SWALLOWING (DYSPHAGIA). A CT SCAN DEMONSTRATED AN INTRAMURAL HEMATOMA ON THE ANTERIOR SIDE OF THE ESOPHAGUS THAT EXTENDED FROM THE LEVEL OF THE CARINA DOWN TO THE GASTROESOPHAGEAL JUNCTION, AND A GASTROGRAFIN SWALLOWING STUDY THE FOLLOWING DAY REDEMONSTRATED ANTERIOR COMPRESSION OF THE ESOPHAGEAL LUMEN. THE PATIENT WAS KEPT IN THE HOSPITAL FOR MONITORING WHILE BEING TAKEN OFF ANTICOAGULANT MEDICATIONS. HE REMAINED STABLE, TOLERATING ORAL LIQUIDS, AND WAS DISCHARGED IN GOOD CONDITION ON (B)(6) 2023. A REPEAT FLUOROSCOPIC ESOPHAGRAM WAS PERFORMED AS AN OUTPATIENT ON (B)(6) 2023, SHOWING COMPLETE RESOLUTION AND A NORMAL APPEARING ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384094 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 68 YR Male Hospitalization CINCINNATI SUB-ZERO SUB-ZERO BLANKETROL III.