BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 13602629 · Received February 25, 2022

    Report

    Report Number
    3009437315-2022-00003
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    October 1, 2021
    Report Date
    February 25, 2022
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10860237000214
    PMA / PMN Number
    K112376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATRIOESOPHAGEAL FISTULA IS UNCOMMON BUT HAS BEEN REPORTED WITH ALL APPROACHES TO ATRIAL FIBRILLATION ABLATION, WITHOUT CLEARLY IDENTIFIABLE PREDISPOSING FACTORS. PROBE WAS DISCARDED BY THE HOSPITAL AFTER USE AND THEREFORE NO INSPECTION OF THE COMPLAINT PROBE COULD BE PERFORMED. LOT NUMBER NOT AVAILABLE AS THE PROBE AND PACKAGING HAD BEEN DISCARDED BY THE HOSPITAL AFTER USE. NO DEFICIENCY OR MALFUNCTION WITH THE TEMPERATURE MONITORING SYSTEM WAS REPORTED BY THE HOSPITAL. THE CIRCA TEMPERATURE PROBE IS PLACED IN THE ESOPHAGUS AND THE CONTINUOUS ESOPHAGEAL TEMPERATURE DATA IS DISPLAYED ON THE CIRCA MONITOR. THE INTERPRETATION AND USE OF THIS DATA IS A THE SOLE DISCRETION OF THE PHYSICIAN.

    Additional Manufacturer Narrative · 0

    ATRIOESOPHAGEAL FISTULA IS UNCOMMON BUT HAS BEEN REPORTED WITH ALL APPROACHES TO ATRIAL FIBRILLATION ABLATION, WITHOUT CLEARLY IDENTIFIABLE PREDISPOSING FACTORS. PROBE WAS DISCARDED BY THE HOSPITAL AFTER USE AND THEREFORE NO INSPECTION OF THE COMPLAINT PROBE COULD BE PERFORMED. LOT NUMBER NOT AVAILABLE AS THE PROBE AND PACKAGING HAD BEEN DISCARDED BY THE HOSPITAL AFTER USE. NO DEFICIENCY OR MALFUNCTION WITH THE TEMPERATURE MONITORING SYSTEM WAS REPORTED BY THE HOSPITAL. THE CIRCA TEMPERATURE PROBE IS PLACED IN THE ESOPHAGUS AND THE CONTINUOUS ESOPHAGEAL TEMPERATURE DATA IS DISPLAYED ON THE CIRCA MONITOR. THE INTERPRETATION AND USE OF THIS DATA IS A THE SOLE DISCRETION OF THE PHYSICIAN.

    Description of Event or Problem · 0

    PHYSICIAN ASKED US TO REPORT THE OCCURRENCE OF A PATIENT WHO HAD AN ESOPHAGEAL FISULA FOLLOWING AN RF ABLATION. CIRCA WAS USED TO MONITOR ESOPHAGEAL TEMPERATURE. PATIENT HAS SINCE RECOVERED. TEE PROBE WAS ALSO USED ON PATIENT FOR WATCHMAN INSERTION.

    Description of Event or Problem · 0

    PHYSICIAN ASKED US TO REPORT THE OCCURRENCE OF A PATIENT WHO HAD AN ESOPHAGEAL FISULA FOLLOWING AN RF ABLATION. CIRCA WAS USED TO MONITOR ESOPHAGEAL TEMPERATURE. PATIENT HAS SINCE RECOVERED. TEE PROBE WAS ALSO USED ON PATIENT FOR WATCHMAN INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357948 S-CATH ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-2001 10860237000214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization RF ABLATION, TEE PROBE, AND WATCHMAN DEVICE