BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 3011134 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00279
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 15, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESISTANCE WAS TESTED ON EACH LEAD AND EACH MET SPEC. THE CUFF WAS INITIATED WITH 20 ML OF AIR WHILE THE CUFF WAS SUBMERGED IN WATER, AND BUBBLES WERE SEEN EXITING THE CUFF ON THE PROXIMAL END, NEAR THE SITE OF ADHESIVE, IN LINE WITH THE LEFT BLUE ELECTRODE. THE ELECTRODE WAS EXAMINED MORE CLOSELY UNDER 20X MAGNIFICATION AND CONFIRMED TO BE LOCATED PROPERLY WITHIN THE LUMEN. WITH SOME MANIPULATION OF THE CUFF, A SMALL TEAR WAS OBSERVED ON THE CUFF. THERE WAS ALSO OBSERVED A SMALL RAGGED CHANNEL RUNNING ALONGSIDE THE TEAR, AS COULD BE CAUSED BY SCRAPING WITH A SHARP OBJECT. THE MOST LIKELY CAUSE OF THE CUFF TEAR IS DURING MFG THE WIRE WAS LIKELY PLACE IMPROPERLY AND MISSED THE SECOND LUMEN OPENING, PUNCTURING THE CUFF WAS NOT ABLE TO BE ENTERED INTO OUR COMPLAINT HANDLING SYSTEM. THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS A MEANS OF PROVIDING BOTH AN OPEN AIRWAY FOR PT 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, APPROX 30MM, SLIGHTLY SUPERIOR TO THE CUFF. THE ELECTRODES ARE DESIGNED TO MAKE CONTACT WITH THE PT'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 PT'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. THERE ARE MANY NON-DEVICE RELATED ISSUES THAT CAN BLOCK A COMPLETED ELECTRICAL CIRCUIT OR INHIBIT A RESPONSE: SUCH AS PARALYTIC ANESTHESIA; NONCONDUCTIVE/DRY TISSUES, OR A NERVE FATIGUED BY OVER STIMULATION. IN ADDITION, DAMAGE TO THE DEVICE OR MISUSE CAN LEAD TO A DEVICE MALFUNCTION. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN FALSELY MISINTERPRET THE INFO AS A NEGATIVE. WHEN INFO SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO CAUSE PT INJURY IT IS ASSUMED THAT THE FAILURE MAY GO UNDETECTED. THEREFORE, WITHOUT INFO 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, NO DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR 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 6MM ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE STATING "AFTER DETAILED CHECKING, EMG TUBE STILL NO RESPONSE WHEN STIMULATING". THERE WAS NO SUGGESTION OF PT INJURY. TESTING/REPAIR COULD NOT CONFIRM THE REPORTED EVENT, BUT DID FIND A SMALL LEAK IN THE CUFF. 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 PT. IF REINTUBATION IS REQUIRED THAT CONSTITUTES MEDICAL INTERVENTION AND MAKES THIS A SERIOUS INJURY. IF NO FURTHER INFO IS PROVIDED OR CAN BE OBTAINED, MEDTRONIC WILL CONSERVATIVELY ASSUME THAT THE REPORTED LEAK IS SMALL AND POSSIBLY UNDETECTABLE IN NATURE AND REQUIRED REINTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108285 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229306 0205587993

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR