BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-CATH ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 16390702 · Received February 16, 2023

    Report

    Report Number
    3009437315-2023-00001
    Event Type
    Death
    Date Received
    February 16, 2023
    Date of Event
    October 6, 2022
    Report Date
    February 16, 2023
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10860237000214
    PMA / PMN Number
    K112376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS REPORTED BY RF ABLATION COMPANY, (B)(6). CIRCA CONTACTED THE HOSPITAL. HOSPITAL STATED THAT THEY DETERMINED NO CAUSE OR ORIGIN OF INJURY FROM EQUIPMENT. ROOT CAUSE WAS NOT THE EQUIPMENT USED DURING PROCEDURE. HOSPITAL HAD NO KNOWLEDGE OF (B)(6) LETTER TO THE FDA.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION (PVI) PROCEDURE, AN ESOPHAGEAL PERFORATION CAUSING SEPSIS IN THE PATIENT. THE TEMPERATURE MONITORING DEVICE WAS ALARMING ABOVE THE MANUFACTURER'S RECOMMENDED HIGH USAGE SUGGESTIONS. THE PATIENT WAS ADMITTED 17 DAYS POST PROCEDURE DUE TO SEPSIS CAUSED FROM AN ESOPHAGEAL PERFORATION THE (SIC) LIKELY OCCURRED DURING THE ABLATION PROCEDURE. PER CT: MEDIASTINUM AND LYMPHATIC, THERE WAS PNEUMOMEDIASTINUM, WITH AIR ANTERIOR TO THE ESOPHAGUS AT THE LEVEL OF THE RIGHT MAIN PULMONARY ARTERY, AND EXPENDING 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
    389936 S-CATH ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-2001 10860237000214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death ABBOTT RF ABLATION