BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK* 2 ENTERAL ACCESS SYSTEM

    MDR report key: 7797925 · Received August 20, 2018

    Report

    Report Number
    3006646024-2018-00029
    Event Type
    Death
    Date Received
    August 20, 2018
    Date of Event
    May 26, 2018
    Report Date
    October 4, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 16-AUG-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE MONITOR UNIT WAS INSPECTED FOR DAMAGES AND BREAKAGES, THERE WERE NO BREAKAGES OR DAMAGES FOUND ON THE BLUE HOUSING AND ORANGE BUTTON. FUNCTIONAL TESTING OF THE UNIT INDICATES THAT THE UNIT WORKS AS INTENDED. AFTER THE SETUP, VERIFICATION OF THE CORTRAK SYSTEM AND THE COMPLETION OF THE INITIALIZATION, THE FUNCTIONALITY OF THE UNIT PERFORMED AS INTENDED. THE COMPLAINT REGARDING THE LUNG PLACEMENT WAS UNABLE TO BE REVIEWED DUE TO THE PLACEMENT TRACINGS NOT BEING PRESENT. THE COMPLAINT WAS NOT CONFIRMED. NO ROOT CAUSE WAS IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    AN FDA USER FACILITY REPORT, MW5078368, WAS RECEIVED STATING "WHILE PLACING A #12F CORTRAK W NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITTING STYLET AND IV CONNECTOR WITH CORTRAK 2 PLACEMENT DEVICE, THE TRACING READ AMBIGUOUSLY AFTER MULTIPLE ATTEMPTS AT PLACEMENT. IT WAS NOTED THAT DURING THE PROCEDURE, THE PT. WHOM HAD DEMENTIA WAS TAKING (?TALKING) AND MOVING REQUIRING THE PROCEDURE TO BE STOPPED AND RESTARTED SEVERAL TIMES STAFF DID NOT TRUST READING AND OBTAINED AN ORDER FOR A CHEST X-RAY TO CONFIRM GASTRIC TUBE PLACEMENT. THE CHEST X-RAY INSTEAD REVEALED THE TUBE HAD ENTERED THE LEFT BRONCHUS AND PERFORATED THE LEFT APICAL LUNG. ONCE THE PERFORATION WAS IDENTIFIED, THE TUBE WAS PULLED AND THE PT. BEGAN TO QUICKLY DECLINE REQUIRING RE-INTUBATION." ADDITIONAL INFORMATION RECEIVED 27-JUL-2018 STATED THE PATIENT DIED ON (B)(6) 2018. PRIOR TO THE INCIDENT THE PATIENT WAS RECOVERING FROM A MYOCARDIAL INFARCTION (MI) AND WAS SCHEDULED TO PROGRESS TO REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639978 CORTRAK* 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 1208020 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death UNKNOWN NG TUBE