BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 3012910 · Received March 1, 2013

    Report

    Report Number
    1045254-2013-00185
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    September 21, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN "AS RECEIVED CONDITION" THE TUBE WAS INFLATED WITH 20CC OF AIR AND IT WAS DETERMINED THAT THE CUFF HAD A SLOW LEAK. WHEN VIEWED UNDER MAGNIFICATION NO DAMAGE COULD BE FOUND HOWEVER WHEN THE CUFF WAS PLACED IN A BEAKER OF WATER THE SOURCE WAS ESTABLISHED WITH AIR BUBBLING OUT. A PUNCTURE WAS FOUND AND MEASURED LESS THAN 0.005 INCH. THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS A MEANS OF PROVIDING BOTH AN OPEN AIRWAY FOR PATIENT VENTILATION AND FOR INTRAOPERATIVE MONITORING OF EMG ACTIVITY OF THE LARYNGEAL MUSCULATURE DURING SURGERY WHEN CONNECTED TO A MULTI-CHANNEL EMG NEUROMONITORING DEVICE. THE EMG ENDOTRACHEAL TUBE IS A FLEXIBLE SILICONE ENDOTRACHEAL TUBE WITH AN INFLATABLE CUFF AND IS FITTED WITH ELECTRODES ON THE MAIN SHAFT OF THE ENDOTRACHEAL TUBE, WHICH ARE EXPOSED ONLY FOR A SHORT DISTANCE, APPROXIMATELY 30MM, SLIGHTLY SUPERIOR TO THE CUFF. THE ELECTRODES ARE DESIGNED TO MAKE CONTACT WITH THE PATIENT'S VOCAL CORDS TO FACILITATE EMG MONITORING OF THE VOCAL CORDS DURING SURGERY WHEN CONNECTED TO AN EMG MONITORING DEVICE. BOTH THE TUBE AND THE CUFF ARE MANUFACTURED FROM MATERIAL THAT ALLOWS THE TUBE TO READILY CONFORM TO THE SHAPE OF THE PATIENT'S TRACHEA WITH MINIMAL TRAUMA TO TISSUES. THE EMG ENDOTRACHEAL TUBE IS PACKAGED AS A STERILE SINGLE-USE DEVICE. NERVE MONITORS ARE MANDATORY FOR USE WITH THE EMG ENDOTRACHEAL TUBE. ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO "MONITOR THE CUFF VOLUME ROUTINELY TO ENSURE AN ADEQUATE SEAL IS MAINTAINED." WHEN INFORMATION SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO CAUSE PATIENT INJURY IT IS ASSUMED THAT THE FAILURE MAY GO UNDETECTED. THEREFORE, WITHOUT INFORMATION TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED A 7MM ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE STATING "AFTER THE ANESTHETIST INSERTS TUBE AND AIR LEAKAGE HAPPENED." A FOLLOW UP WITH THE CUSTOMER INDICATES THAT THE INTUBATION PROCEDURE WAS COMPLETE WHEN THE AIR LEAK WAS DISCOVERED. IT IS UNCLEAR WHETHER OR NOT THE PATIENT WAS REINTUBATED TO CORRECT THE PROBLEM. THERE WAS NO SUGGESTION OF PATIENT INJURY. ANALYSIS OF THE DEVICE CONFIRMED THAT THERE WAS A PUNCTURE THAT MEASURED LESS THAN 0.005 INCH. THIS INFORMATION INDICATES THAT THERE WAS A CUFF LEAK DURING THE PROCEDURE THAT HAD THE POTENTIAL TO GO UNDETECTED. THIS IS IN REFERENCE TO THE AIR SYSTEM OF THE CUFF AND PILLOW (INFLATION LUMEN). SMALL UNDETECTED CUFF LEAKS (SUCH AS PIN HOLES OR PUNCTURES BY A LEAD WIRE) HAVE RESULTED IN INTRAOPERATIVE CUFF DEFLATION. INTRAOPERATIVE CUFF DEFLATION AFFECTS THE VENTILATION OF THE PATIENT. IT WILL CONSERVATIVELY BE ASSUMED THAT THE REPORTED LEAK IS SMALL AND POSSIBLY UNDETECTABLE IN NATURE AND COULD REQUIRE REINTUBATION IF THE EVENT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90258 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229307 0205897720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR