BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSITHERM PROBE

    MDR report key: 17287621 · Received July 10, 2023

    Report

    Report Number
    3003072803-2023-00002
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    May 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    FIAB S.P.A.
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. THE EVENT OCCURRED IN EU (FRANCE) NOT IN US. 2. THE PRODUCT REPORTED INVOLVED IN THE INCIDENT - MODEL 26155ST - IS SIMILAR TO THE PRODUCT CLEARED FOR THE MARKETING IN US UNDER THE 510(K) K123361 AND MODEL 26155S/US, HOWEVER THIS LATTER IS NOT SOLD IN THE US SINCE 2019 AND CURRENTLY DISMISSED IN FIAB PORTFOLIO. 3. THE SAMPLE OF THE DEVICE INVOLVED IN THIS INCIDENT IS NOT AVAILABLE YET, BUT IS BEING RETURNED TO FIAB FOR EXAMINATION. THE PRELIMINARY ASSESSMENT IS BASED ON THE AVAILABLE INFORMATION AND IT'S EXPECTED TO BE CONFIRMED AFTER THE DEVICE RETURN, UNLESS THE RETURNED PROBE WILL SHOW SEVERE DEFECTIVENESS / NON COMPLIANCE WITH EXPECTED SPECIFICATIONS (I.E. FROM A DIMENSIONAL STANDPOINT OR THE PRESENCE OF ANOMALIES ON SHAPE, PRESENCE OF SHARP EDGES ETC). 4. IT IS DEEMED NOT CORRECT IDENTIFYING THE PROBE 26155ST ITSELF AS THE CAUSE OF THE EPISTAXIS EVENT, INSTEAD OF CONSIDERING THE EPISTAXIS AS A POSSIBLE AND EXPECTED OCCURRENCE DURING ANY KIND OF TOOL INTRODUCTION INSIDE A HIGHLY VASCULARIZED BODY AREA. THERE IS NO INHERENT CHARACTERISTIC OF THE PROBE 26155ST ITSELF THAT CAN CAUSE DAMAGE OTHER THAN ITS FRICTION AGAINST DELICATE TISSUES CAUSED BY A ROUGH INTRODUCTION OR PREVIOUSLY. MOREOVER THE INFORMATION FROM THE HEALTHCARE FACILITY INDICATES THAT THE PATIENT WAS UNDER ANTI-COAGULANT TREATMENT AND THIS IS A KEY FACTOR THAT CAN PROLONGE / INCREASE THE EPIXTASIS.

    Description of Event or Problem · 0

    DURING THE AF ABLATION PROCEDURE, THE USER SET UP THE TEMPERATURE MONITORING PROBE (26155ST LOT 23CB0078) IN NASAL CAVITY BUT THAT WAS A FAILURE. THEY TRIED TO PLACE THE PROBE ORALLY, BUT AN EPISTAXIS APPEARED. AT THE END OF THE PROCEDURE, THE EPISTAXIS INTENSIFIED REQUIRING AN EMBOLIZATION TO STOP THE BLEEDING. THE PATIENT HAD TO BE MOVED TO INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180898 SENSITHERM PROBE ESOPHAGEAL CATHETER FOR TEMPERATURE MEASUREMENT FLL FIAB S.P.A. 26155ST 23CB0078

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention