BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMT BRIDLE NASAL TUBE RETAINING SYSTEM

    MDR report key: 3234200 · Received July 12, 2013

    Report

    Report Number
    1526012-2013-00005
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 2, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY INC
    Product Code
    KNT
    PMA / PMN Number
    K030784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. AFTER REVIEW OF THE REPORTED EVENT, IT IS BELIEVED THAT THE INFO OBTAINED IN THE REPORT IS ERRONEOUS, AND THAT THE DEVICE WAS USED IMPROPERLY AND DANGEROUSLY. DUE TO THE IMPROPER USE OF THE DEVICE, INTERVENTION WAS REQUIRED TO REMOVE THE ORANGE GUIDEWIRE FROM THE PT'S NARES. IT IS REPORTED THAT BOTH PROBES WERE INSERTED INTO THE NOSE. PRIOR TO THE MAGNETS MAKING CONTACT, THE PT BEGAN COUGHING. AFTER THE COUGHING EPISODE WAS OVER, THE BLUE PROBE WAS REPORTEDLY 3/4 OUTSIDE OF THE PT'S NOSE WHILE THE WHITE PROBE AND ORANGE GUIDEWIRE WERE PULLED INTO THE OPPOSITE NOSTRIL. THERE ARE SEVERAL THINGS WRONG WITH THIS DESCRIPTION. FIRST, THE EVENT DESCRIPTION REPORTS THAT THE MAGNETS DID NOT MAKE CONTACT PRIOR TO THE COUGHING EPISODE. THIS MEANS THAT THE BLUE PROBE COULD NOT HAVE PULLED THE WHITE PROBE AND ORANGE GUIDEWIRE INTO THE PT'S NARES DURING THE COUGHING EPISODE. EVEN IF THE MAGNETS HAD ATTACHED PRIOR TO THE COUGHING EPISODE, THE MAGNETS WOULD HAVE DETACHED AT A FORCE BELOW WHAT WOULD BE REQUIRED TO PULL THE ORANGE GUIDEWIRE HANDLE INTO THE NOSTRIL. SECOND, COUGHING PRODUCES A FORCE THAT EXITS THE BODY, WHICH WOULD HAVE EXPELLED THE WHITE PROBE AND ORANGE GUIDE WIRE FROM THE NOSE, NOT SUCK THEM IN DEEPER AS REPORTED. IF THE REPORTED WAS ACCURATE, COUGHING WOULD HAVE EXPELLED THE WHITE PROBE AND ORANGE GUIDEWIRE FROM THE NOSTRIL JUST AS IT DID WITH THE BLUE PROBE. IT IS BELIEVED THAT WHAT ACTUALLY OCCURRED IS THE PROCEDURE WAS DONE INCORRECTLY AND DANGEROUSLY, AND THE DIRECTIONS OF USE WERE NOT FOLLOWED. THE EVENT IS BELIEVED TO HAVE OCCURRED IN A SIMILAR MANNER AS REPORT #: (B)(4), WHICH INVOLVED MOST AN IDENTICAL OUTCOME. THE FORCE REQUIRED TO LODGE THE ORANGE PROBE INTO THE NARES COULD HAVE ONLY OCCURRED BY EXTERNAL FORCE BY THE USER PLACING THE DEVICE. PLEASE NOTE THAT APPLIED MEDICAL TECHNOLOGY HAS MADE SEVERAL ATTEMPTS TO SEND EMPLOYEES TO THE HOSPITAL TO PROPERLY TRAIN ALL PERSONNEL. AMT HAS BEEN TURNED DOWN ON EVERY OFFER, SO THE HOSPITAL CONTINUES TO USE THE DEVICE DANGEROUSLY W/O PROPER TRAINING. PLEASE NOTED THAT THIS EVENT HAS OCCURRED TWICE AT THIS HOSPITAL, AND HAS NOT OCCURRED AT ANY OTHER LOCATION. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES. NOR WAS THE AMT DEVICE RETURNED TO AMT FOR ANALYSIS. AMT WILL PROVIDE ADD'L INFO TO THE FDA WHEN/IF THE DEVICE IS ABLE TO BE RETRIEVED AND ANALYSIS OF THE DEVICE CHANGES THE CONCLUSIONS OF THIS REPORT.

    Description of Event or Problem · 1

    TITLE: XXXXX. BRIDLE WAS IN PROCESS OF BEING PLACED WHEN PT STARTED COUGHING. BOTH GUIDE ENDS OF MAGNET GUIDES HAD BEEN FULLY ADVANCED, BUT NO 'CLICK' HAD BEEN FELT PRIOR TO PT'S COUGHING AND SPITTING FIT. AFTER PT RELAXED, THE BLUE PORT WAS 3/4 OF THE WAY OUT OF PT'S NOSE AND ORANGE END OF GUIDEWIRE WAS NOT NOTED. AFTER COMPLETELY REMOVING THE BLUE GUIDE AND INSPECTING PT'S NARE, RN REALIZED THAT THE WIRE WAS STILL INSIDE OF PT'S NOSE WIRE WAS SECURED SO IT WOULD NOT FALL BACK INTO PT'S THROAT. NG TUBE WAS REMOVED TO SEE IF WIRE WOULD COME FREE, MD WAS NOTIFIED AND ENT WAS PAGED FOR REMOVAL OF GUIDE WIRE WITH SCOPE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TUBE FEEDING. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321868 AMT BRIDLE NASAL TUBE RETAINING SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY INC NA 13043266

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other