BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACOE TWIST TRACHEOSTOMY CANNULA

    MDR report key: 22827484 · Received August 18, 2025

    Report

    Report Number
    8010485-2025-49228
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    June 21, 2025
    Report Date
    August 18, 2025
    Manufacturer
    TRACOE MEDICAL GMBH
    Product Code
    JOH
    UDI-DI
    04035324016884
    PMA / PMN Number
    K961449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER ERROR - NO CHECKING OF THE INFLATION LINE FOR TRAPPING/PINCHING. THE DEFECT COULD NOT BE VERIFIED, AS NO SAMPLE OR PHOTO WAS PROVIDED. A THEORETICAL INVESTIGATION WAS CONDUCTED BASED ON THE COMPLAINT DESCRIPTION. ACCORDING TO THE REPORT, THE INFLATION LINE BECAME TRAPPED BETWEEN THE INNER AND OUTER CANNULA DURING INSERTION, PREVENTING PROPER CUFF INFLATION. TRACEABILITY OF LOT 1100038852 (MAN 2024-08-19) SHOWED NO RECURRENCE OF THIS ISSUE. PRODUCTION RECORDS, INCLUDING THE CUFF INFLATION LINE (ART. 300080.08, LOT 240423/1/2/3), REVEALED NO DEVIATIONS OR ANOMALIES. THE COMPLAINT DESCRIPTION INDICATES THAT THE ISSUE OCCURRED DURING USE, LIKELY DUE TO THE INFLATION LINE BEING PINCHED DURING INSERTION. THIS IS ADDRESSED IN THE IFU (CHAPTER 5), WHICH INSTRUCTS USERS TO CHECK THAT THE INFLATION LINE IS NOT TRAPPED BETWEEN CANNULA COMPONENTS. BASED ON CURRENT EVIDENCE, THE ROOT CAUSE IS ASSESSED AS USER ERROR.

    Description of Event or Problem · 0

    1) WHAT WENT WRONG: DURING A TRACHEOSTOMY PROCEDURE USING THE TRACOE EXPERC SET (REF (B)(4) WITH CANNULA MODEL 306-08-P, A MALFUNCTION OCCURRED AT THE STAGE OF INSERTING AND LOCKING THE INNER CANNULA. THE CONNECTION TUBE (FILLING LINE) BETWEEN THE CUFF AND THE PILOT BALLOON BECAME INADVERTENTLY TRAPPED BETWEEN THE OUTER AND INNER CANNULAE WITHIN THE LOCKING MECHANISM. AS A RESULT, THE CUFF COULD NOT BE INFLATED PROPERLY DUE TO COMPRESSION OF THE CUFF TUBING. EVEN AFTER THE CONNECTION TUBE WAS RELEASED, THE INFLATION SYSTEM DID NOT FUNCTION AS EXPECTED. HIGHER-THAN-NORMAL INFLATION PRESSURES WERE REQUIRED, AND DEFLATION/ASPIRATION FROM THE CUFF REMAINED INCOMPLETE. CONSEQUENTLY, EFFECTIVE PATIENT VENTILATION COULD NOT BE ENSURED - BECAUSE OF THE REDUCED BLOCKING OF THE CUFF. 2) HEALTH EFFECT: THE PATIENT HAD TO UNDERGO EMERGENCY OROTRACHEAL INTUBATION FOLLOWED BY A REPEAT TRACHEOTOMY, WHICH WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATION NO FURTHER HEALTH EFFECT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193840 TRACOE TWIST TRACHEOSTOMY CANNULA TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE AND INSERTER JOH TRACOE MEDICAL GMBH REF 306-08-P 1100038852 04035324016884

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention