BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 19567288 · Received June 19, 2024

    Report

    Report Number
    9611594-2024-00110
    Event Type
    Death
    Date Received
    June 19, 2024
    Date of Event
    May 24, 2024
    Report Date
    February 4, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984308
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 JUN 2024 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 · 0

    THE DEVICE HISTORY RECORD FOR LOT 30268292 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 04 FEB 2025 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 · 0

    ADDITIONAL INFORMATION: B5, D10, H6. ALL INFORMATION REASONABLY KNOWN AS OF 11 SEP 2024 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2024-00109 FOR THE FIRST REPORT. IT WAS REPORTED, "LAST WEEK WE HAD AN ISSUE WITH SOME OF THE GASTROPEXIES USED ON A PATIENT. THE DAY AFTER RIG INSERTION AT LEAST TWO OF THE GASTROPEXIES SNAPPED OFF (THREE HAD BEEN INSERTED DURING PROCEDURE).¿ PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 , RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) WAS INSERTED ON (B)(6) 2024 AND PATIENT UNFORTUNATELY PASSED AWAY ON (B)(6) 2024. ¿THE DEATH WAS LIKELY IN SOME WAY RELATED TO THE GASTROPEXIES. AS THE GASTROPEXIES HAD FALLEN OUT VERY SOON AFTER THE PROCEDURE, PATIENT HAD ONGOING ISSUES WITH LOOSE RIG AS THE TRACT WASN¿T STABLE. THE BALLOON MIGRATED OUT OF THE STOMACH AND INTO THE PERITONEUM LIKELY CONTRIBUTING TO PATIENT DEATH.¿

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED ON 27AUG2024, ¿THE WHITE DISCS ON THE GASTROPEXIES CAME OFF. THE TUBE PLACED WAS OUR STANDARD 12FRENCH MIC TUBE. I BELIEVE THE PATIENT DID DEVELOP PERITONITIS AFTER THE PROCEDURE. THIS WAS AN UNEXPECTED EVENT AND NOT DIRECTLY RELATED TO ANOTHER ONGOING HEALTH ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654263 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98430 30268292 00350770984308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| O| D AVANOS MIC GASTRONOMY TUBE, 12FR