BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 18093050 · Received November 8, 2023

    Report

    Report Number
    3010412492-2023-00005
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 8, 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
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, THE EXACT CAUSE OF THE PATIENT'S BLEEDING CANNOT BE CONCLUSIVELY DETERMINED. POTENTIAL FACTORS THAT COULD HAVE CONTRIBUTED TO OR CAUSED THIS PATIENT'S BLEEDING INCLUDE: (1) OROPHARYNGEAL TRAUMA FROM A DIFFICULT INTUBATION, (2) PRE-EXISTING ESOPHAGITIS, OR (3) THE USE OF PROCEDURAL ANTICOAGULATION. FURTHERMORE, THE ENSOETM COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S BLEEDING BY ABRADING ESOPHAGEAL MUCOSA THAT HAD BEEN COMPROMISED BY PRE-EXISTING ESOPHAGITIS.

    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 AND WAS INTUBATED WITH A STANDARD ENDOTRACHEAL TUBE. INTUBATION WAS PERFORMED BY A TRAINEE WHO EXPERIENCED DIFFICULTY COMPLETING THE INTUBATION AND REQUIRED MULTIPLE ATTEMPTS TO PLACE THE ENDOTRACHEAL TUBE. THE ENSOETM WAS SUCCESSFULLY PLACED INTO THE ESOPHAGUS WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. UPON WITHDRAWAL OF THE ENSOETM AFTER THE END OF THE PROCEDURE, A SMALL AMOUNT OF BLOOD WAS DISCOVERED IN THE OROPHARYNX. THE SOURCE OF THE BLOOD WAS UNCLEAR, BUT IT WAS INITIALLY PRESUMED TO BE FROM OROPHARYNGEAL TRAUMA FROM THE DIFFICULT INTUBATION. AS A RESULT, THE CLINICAL TEAM ELECTED TO KEEP THE PATIENT ENDOTRACHEALLY INTUBATED WHILE FURTHER EVALUATION WAS UNDERTAKEN IN THE INTENSIVE CARE UNIT (ICU). IN THE ICU OVER THE FOLLOWING DAY, THE PATIENT HAD A CT SCAN OF THE CHEST, SHOWING A DIFFUSELY THICKENED ESOPHAGUS SUGGESTIVE OF ESOPHAGITIS. AN ENDOSCOPY SHOWED EVIDENCE OF OROPHARYNGEAL TRAUMA, BUT WITHOUT A CLEAR SOURCE OF ANY BLEEDING AND NO ESOPHAGEAL PERFORATION. IN THE DISTAL ESOPHAGUS A SMALL TEAR WAS DISCOVERED THAT WAS NOT BLEEDING, BUT IT WAS SUSPECTED THIS TEAR COULD HAVE BEEN THE SOURCE OF BLOOD SEEN PREVIOUSLY IN THE OROPHARYNX. NO TREATMENT WAS REQUIRED, AND NO FURTHER EVIDENCE OF BLEEDING WAS DISCOVERED. THE PATIENT WAS SUCCESSFULLY EXTUBATED, FULLY RECOVERED, AND DISCHARGED THE NEXT DAY WITH ANTICOAGULATION RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689038 ENSOETM ESOPHAGEAL THERMAL REGULATION DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD02-A 199115223 00857915006180

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization CINCINNATI SUB-ZERO/GENTHERM BLANKETROL III.