BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSOETM

    MDR report key: 14048358 · Received April 7, 2022

    Report

    Report Number
    3010412492-2022-00001
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    February 9, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
    Product Code
    PLA
    UDI-DI
    10857915006187
    PMA / PMN Number
    K172493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTUNE MEDICAL DETERMINED IT IS REASONABLE TO CONCLUDE THAT (1) IT IS UNLIKELY THE ENSOETM CONTRIBUTED TO THE PATIENT'S INTRAVASCULAR VOLUME IN A CLINICALLY SIGNIFICANT WAY, (2) THE ENSOETM DID NOT MALFUNCTION DUE TO ITS DESIGN OR MANUFACTURING PROCESSES, AND (3) THE LEAK IN THE ENSOETM WAS MOST LIKELY CAUSED BY A SHARP OBJECT LOCATED IN OR AROUND THE PATIENT'S MOUTH DURING PLACEMENT OR USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2022. AN ENSOETM WAS INSERTED TO THE COOL THE PATIENT'S ESOPHAGUS DURING THE PROCEDURE. THE DEVICE WAS INSPECTED FOR LEAKS PRIOR TO INSERTION, AND NO LEAKS WERE NOTED PRIOR TO INSERTION. AFTER INSERTION, A SMALL AMOUNT OF FLUID WAS NOTED IN THE PATIENT'S MOUTH. AT THIS TIME, THE ENSOETM WAS PARTIALLY REMOVED FROM THE ESOPHAGUS AND INSPECTED FOR LEAKS, AND A "SMALL TRICKLE" OF WATER WAS NOTED. HOWEVER, THIS FLUID WAS INITIALLY BELIEVED TO BE ORAL SECRETIONS FROM THE MOUTH AND THE ENSOETM WAS REPLACED. UPON RE-INSERTING THE ENSOETM IN THE ESOPHAGUS, MORE FLUID WAS NOTED IN THE PATIENT'S MOUTH, AND THE ENSOETM WAS AGAIN REMOVED AND INSPECTED FOR LEAKS. AT THIS TIME, A STEADY STREAM OF WATER WAS NOTED TO BE LEAKING FROM THE SIDE OF THE TUBE NEAR THE LOCATION ON THE DEVICE WHERE THE PATIENT'S MOUTH WAS LOCATED. THE LEAKING ENSOETM WAS REPLACED WITH A NEW ENSOETM, AND THE REMAINDER OF THE ABLATION PROCEDURE PROCEEDED WITHOUT INCIDENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS HELD IN THE HOSPITAL TO ALLOW A SUFFICIENT NUMBER OF HEMODIALYSIS SESSIONS TO RESTORE THE PATIENT TO THEIR OPTIMAL WEIGHT AND HEMODYNAMIC STATUS. THESE SESSIONS WERE PRE-PLANNED DUE TO THE PATIENT'S BASELINE CONGESTIVE HEART FAILURE, END STAGE RENAL DISEASE, AND MISSED HEMODIALYSIS SESSIONS, COMBINED WITH THE FLUID ADDED TO THE PATIENT'S CIRCULATION VIA THE IRRIGATION OF THE RADIOFREQUENCY CATHETER. FOLLOWING THE PRE-PLANNED HEMODIALYSIS SESSIONS, THE PATIENT WAS SUCCESSFULLY DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486622 ENSOETM ESOPHAGEAL THERMAL REGULATION DEVICE PLA ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ECD02-A 199123521 10857915006187

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R CINCINNATI SUB-ZERO BLANKETROL III| CINCINNATI SUB-ZERO BLANKETROL III