BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 18842104 · Received March 5, 2024

    Report

    Report Number
    3010412492-2024-00001
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 4, 2024
    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
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, THE EXACT CAUSE OF THE PATIENT'S SUPERFICIAL ULCER AT THE DISTAL THIRD OF THE ESOPHAGUS WITH STIGMATA OF RECENT BLEEDING CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTING FACILITY STATED THE ENSOETM WAS SUCCESSFULLY PLACED AND THE ABLATION PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THE ATRAUMATIC NATURE OF THE ENSOETM (WITH SOFT, MEDICAL GRADE SILICONE) IS UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO AN ESOPHAGEAL ULCER BUT CANNOT BE CONCLUSIVELY RULED OUT. THE PATIENT CONTINUES TO RECOVER WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A LEFT ATRIAL ABLATION PROCEDURE ON MONDAY, (B)(6) 2024. THE ENSOETM WAS PLACED SUCCESSFULLY WITHOUT DIFFICULTY, AND PROPER POSITION WAS CONFIRMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THE TIME OF PLANNED DISCHARGE THE NEXT MORNING, THE PATIENT FELT LIGHTHEADED, PROMPTING ADDITIONAL WORKUP. THE PATIENT'S HEMOGLOBIN WAS FOUND TO BE LOW (4.9 G/DL, FROM A PREVIOUS LEVEL OF 12 G/DL), BUT THE PATIENT DID NOT HAVE HEMATEMESIS, MELENA, OR ANY OTHER ADDITIONAL SYMPTOMS AT THIS TIME. A CT ANGIOGRAM OF CHEST, ABDOMEN, AND PELVIS WAS NEGATIVE FOR ANY ETIOLOGY. THE PATIENT RECEIVED A TRANSFUSION OF A TOTAL OF 5 UNITS OF PACKED RED BLOOD CELLS AND SUBSEQUENTLY DEVELOPED MELANOTIC STOOLS, BUT DID NOT EXPERIENCE ANY HEMATEMESIS. ON (B)(6) 2024, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED WHICH SHOWED A SUPERFICIAL ULCER AT THE DISTAL THIRD OF THE ESOPHAGUS WITH STIGMATA OF RECENT BLEEDING, AND BLOOD IN THE STOMACH. THE LOCATION OF THE LESION IN RELATION TO ANTERIOR/POSTERIOR DIMENSION OF THE ESOPHAGUS WAS UNCERTAIN ON INITIAL IMAGING, AND GASTROENTEROLOGY COULD NOT DEFINE THE CIRCUMFERENTIAL LOCATION OF THE LESION. THE SITE HAD NO ACTIVE BLEEDING VISIBLE, BUT A CLIP WAS PLACED UNDER THE PRESUMPTION THAT THIS WAS THE SOURCE OF BLOOD LOSS. THE PATIENT WAS MONITORED FOR AN ADDITIONAL 2 DAYS IN THE HOSPITAL, AND REMAINED STABLE, WITH NO FURTHER EVIDENCE OF BLOOD LOSS. THE PATIENT WAS DISCHARGED AND RETURNED FOR FOLLOW-UP ON (B)(6) 2024, WHERE THEY WERE FOUND TO BE DOING WELL. A SECOND FOLLOW-UP ON (B)(6) 2024 INCLUDED AN EGD WHICH SHOWED NO NEW FINDINGS. THE PATIENT CONTINUES TO RECOVER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138329 ENSOETM ESOPHAGEAL THERMAL REGULATING DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD02-A NOT KNOWN 00857915006180

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization CINCINNATI SUB-ZERO/GENTHERM BLANETROL III.