BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS-1000 TEMPERATURE PHYSIO MONITOR

    MDR report key: 16121900 · Received January 6, 2023

    Report

    Report Number
    MW5114221
    Event Type
    Death
    Date Received
    January 6, 2023
    Date of Event
    October 6, 2022
    Report Date
    January 4, 2023
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT UNDERWENT A CARDIAC ABLATION. DURING THE PROCEDURE THE TEMPERATURE MONITORING DEVICE WAS ALARMING ABOVE THE MANUFACTURER'S RECOMMENDED HIGH USAGE SUGGESTIONS. PATIENT ADMITTED 17 DAYS POST PROCEDURE FOR SEPSIS. IT WAS DISCOVERED THE CAUSE WAS AN ESOPHAGEAL PERFORATION LIKELY CAUSED DURING THE ABLATION. PER CT: MEDIASTINUM AND LYMPHATIC: THERE IS PNEUMOMEDIASTINUM, WITH AIR ANTERIOR TO THE ESOPHAGUS AT THE LEVEL OF THE RIGHT MAIN PULMONARY ARTERY, AND EXTENDING INFERIORLY ALONG THE POSTERIOR MARGIN OF THE LEFT ATRIUM. IT IS SUSPECTED TO ARISE FROM ESOPHAGEAL PERFORATION AT THE LEVEL OF THE MID ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439314 CS-1000 TEMPERATURE PHYSIO MONITOR THERMOMETER, ELECTRONIC, CLINICAL OAD CIRCA SCIENTIFIC, INC. CS-1000
    439315 AMPERE RADIOFREQUENCY GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST JUDE MEDICAL H700488

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death