BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 12178326 · Received July 15, 2021

    Report

    Report Number
    3009437315-2021-00001
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    May 21, 2020
    Report Date
    July 15, 2021
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PROBE WAS DISCARDED BY THE HOSPITAL AFTER USE AND THEREFORE NO VISUAL INSPECTION OF THE COMPLAINT PROBE COULD BE PERFORMED. THE MANUFACTURER PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS, LABELLING AND EVALUATION OF A SAMPLE PROBE FROM RELEASED STOCK, ENGINEERING CHANGE REVIEW, DESIGN REVIEW AND COMMUNICATION WITH THE PHYSICIAN AND CIRCA SCIENTIFIC CLINICAL ADVISOR. THERE WAS NO IDENTIFIED LABELLING PROBLEM OR PRODUCT CHANGE OR DEFECT THAT WOULD ATTRIBUTE TO THE OESOPHAGEAL HAEMATOMA. REASON FOR HAEMATOMA IS INDETERMINATE AS IT MAY HAVE BEEN A COMBINATION OF OTHER PROCEDURE (TEE), PATIENT ANATOMY, AND UNKNOWN RESISTANCE DURING PROBE INSERTION.

    Description of Event or Problem · 1

    S-CATH M PROBE USED DURING ROUTINE PVI WITH MEDTRONIC ACHIEVE CRYO BALLOON. TEE PERFORMED PRE-PROCEDURE, WITH SORE THROAT REPORTED POST TEE, OTHERWISE UNREMARKABLE. IMMEDIATELY POST WAKING FROM PVI PATIENT REPORTED CHEST PAIN. DISMISSED INITIALLY AS TYPICAL POST PROCEDURE PAIN. ONE DAY POST PROCEDURE PATIENT CONTINUED TO REPORT CHEST PAIN WITH BLOOD IN STOOL AND REDUCED HAEMOGLOBIN. GASTROSCOPY PERFORMED SHOWING "LONG HEMI-CIRCUMFERENTIAL HAEMATOMA ! HALF THE LUMEN". PHYSICIAN REPORTED UNREMARKABLE CS-46EP PROBE INSERTION EXCEPT FOR POSSIBLY SOME RESISTANCE IN THE LAST ¼ OF INSERTION BUT NOTHING THAT WAS ALARMING. PROBE WAS DISCARDED AFTER CASE BEFORE ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074529 S-CATH M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-46EP 12590-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization