BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSOETM

    MDR report key: 17148238 · Received June 16, 2023

    Report

    Report Number
    3010412492-2023-00003
    Event Type
    Death
    Date Received
    June 16, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 16, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, THERE IS NO REASONABLE MECHANISM BY WHICH THE ENSOETM COULD CAUSE A THERMAL INSULT TO THE ESOPHAGUS NECESSARY TO CREATE A FISTULA. HOWEVER, IF THE ENSOETM WAS NOT INSERTED TO THE APPROPRIATE DEPTH, IT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT BY FAILING TO EFFECTIVELY COOL THE ESOPHAGUS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2023 THAT UTILIZED THE ENSOETM TO COOL THE ESOPHAGUS DURING THE PROCEDURE. THE ABLATION PROCEDURE WAS NOTED TO BE SUCCESSFUL WITHOUT ANY ACUTE INCIDENTS. ON (B)(6) 2023 , THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF STROKE. WORKUP OVER THE FOLLOWING DAYS SUGGESTED THE ETIOLOGY OF THE PATIENT'S ILLNESS WAS AN ATRIOESOPHAGEAL FISTULA. THE PATIENT'S CONDITION CONTINUED TO WORSEN, AND THE PATIENT DIED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462422 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 82 YR Female Death CINCINNATI SUB-ZERO/GENTHERM BLANKETROL III