BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMT G-JET

    MDR report key: 13486473 · Received February 8, 2022

    Report

    Report Number
    1526012-2022-00001
    Event Type
    Death
    Date Received
    February 8, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 8, 2022
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071116750
    PMA / PMN Number
    K123716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD HAS BEEN MADE TO DOCUMENT A DEATH THAT WAS REPORTED TO AMT BY (B)(6) CHILDREN'S HOSPITAL OF (B)(6) ON (B)(6) 2022. THE PROVIDED INFORMATION THAT WE HAVE AT THIS TIME INDICATES THAT THE PATIENT EXPERIENCED A PERFORATION OF THE GUT ON THE WEEKEND OF (B)(6) 2021, AT (B)(6) KG WEIGHT, AND HAS SINCE PASSED AWAY AT (B)(6) OLD. AMT HAS BEEN IN CONTACT WITH THE REPORTER TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED CASE AND PATIENT CONDITIONS. IT WAS DOCUMENTED THAT THE REPORTER BELIEVED THAT THE DEVICE WAS NOT KEPT, SO IS UNLIKELY TO BE PROVIDED FOR EXAMINATION. WE HAVE ATTEMPTED TO GET CLARIFICATION WHETHER THE DEVICE HAS FOR CERTAIN BEEN DESTROYED. THERE HAS BEEN NO INDICATION OF MALFUNCTION OR DEFECT REPORTED AT THIS TIME, SO EXACT CAUSE FOR GUT PERFORATION AND DEATH IS STILL BEING INVESTIGATING WITH THE REPORTER. THE ORIGINAL NOTIFICATION TO AMT INDICATED THAT THE MICRO G-JET HAD BEEN PLACED, BUT IT WAS LATER VERIFIED THAT THE LOW PROFILE G-JET HAD BEEN PLACED INSTEAD. AMT HAS OPENED UP COMPLAINT #: (B)(4) TO DOCUMENT OUR INVESTIGATION. WE WILL UPDATE THIS MAUDE REPORT SHOULD ADDITIONAL INFORMATION BE GATHERED FROM THE REPORTER THAT CHANGES THE OUTCOME OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    THIS RECORD HAS BEEN MADE TO DOCUMENT A DEATH THAT WAS REPORTED TO AMT BY (B)(6) CHILDREN'S HOSPITAL OF (B)(6) ON (B)(6) 2022. THE PROVIDED INFORMATION THAT WE HAVE AT THIS TIME INDICATES THAT THE PATIENT EXPERIENCED A PERFORATION OF THE GUT ON THE WEEKEND OF (B)(6) 2021, AT (B)(6) KG WEIGHT, AND HAS SINCE PASSED AWAY AT (B)(6) OLD. AMT HAS BEEN IN CONTACT WITH THE REPORTER TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED CASE AND PATIENT CONDITIONS. IT WAS DOCUMENTED THAT THE REPORTER BELIEVED THAT THE DEVICE WAS NOT KEPT, SO IS UNLIKELY TO BE PROVIDED FOR EXAMINATION. WE HAVE ATTEMPTED TO GET CLARIFICATION WHETHER THE DEVICE HAS FOR CERTAIN BEEN DESTROYED. THERE HAS BEEN NO INDICATION OF MALFUNCTION OR DEFECT REPORTED AT THIS TIME, SO EXACT CAUSE FOR GUT PERFORATION AND DEATH IS STILL BEING INVESTIGATING WITH THE REPORTER. THE ORIGINAL NOTIFICATION TO AMT INDICATED THAT THE MICRO G-JET HAD BEEN PLACED, BUT IT WAS LATER VERIFIED THAT THE LOW PROFILE G-JET HAD BEEN PLACED INSTEAD. AMT HAS OPENED UP COMPLAINT #: (B)(4) TO DOCUMENT OUR INVESTIGATION. WE WILL UPDATE THIS MAUDE REPORT SHOULD ADDITIONAL INFORMATION BE GATHERED FROM THE REPORTER THAT CHANGES THE OUTCOME OF THIS REPORT.

    Description of Event or Problem · 0

    ORIGINAL REPORTER INDICATED THAT A LOW-PROFILE G-JET WAS PLACED IN A (B)(6) OLD, (B)(6) KG PATIENT ON (B)(6) 2021. ON THE WEEKEND OF (B)(6) 2022, IT WAS NOTED THAT THE PATIENT EXPERIENCED A TUBE PERFORATION THROUGH THE GUT AND THE PATIENT PASSED AWAY. THE PATIENT WEIGHT WAS PROVIDED AS (B)(6) KG AT THE TIME THE PERFORATION OCCURRED. AWAITING ADDITIONAL INFORMATION REGARDING EVENT AND DETAILS OF OCCURRENCE. THERE HAS BEEN NO INDICATION OF MALFUNCTION OR DEFECT AT THIS TIME.

    Description of Event or Problem · 0

    ORIGINAL REPORTER INDICATED THAT A LOW-PROFILE G-JET WAS PLACED IN A (B)(6) OLD, (B)(6) KG PATIENT ON (B)(6) 2021. ON THE WEEKEND OF (B)(6) 2022, IT WAS NOTED THAT THE PATIENT EXPERIENCED A TUBE PERFORATION THROUGH THE GUT AND THE PATIENT PASSED AWAY. THE PATIENT WEIGHT WAS PROVIDED AS (B)(6) KG AT THE TIME THE PERFORATION OCCURRED. AWAITING ADDITIONAL INFORMATION REGARDING EVENT AND DETAILS OF OCCURRENCE. THERE HAS BEEN NO INDICATION OF MALFUNCTION OR DEFECT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289827 AMT G-JET LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1415-15-I 210723-424 00842071116750

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Unknown Death