BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO G-JET

    MDR report key: 14364955 · Received May 11, 2022

    Report

    Report Number
    1526012-2022-00007
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 11, 2022
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071124342
    PMA / PMN Number
    K183508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REPORTED INFORMATION, IT WAS DETERMINED ON THAT AN ADVERSE EVENT SHOULD BE REPORTED TO FDA AS A JEJUNAL PERFORATION WAS FOUND IN THE SMALL INTESTINES OF THE PATIENT AFTER A MICRO G-JET PLACEMENT. HOWEVER, IT IS UNCLEAR AS TO WHAT CAUSED THE PERFORATION TO OCCUR. THE INFORMATION PROVIDED TO THE AMT SALES REPRESENTATIVE REGARDING THE PERFORATION WAS THAT IT WAS NOT RELATED TO THE MICRO G-JET DEVICE. THE PATIENT HAD PREVIOUSLY HAD A GASTRIC BUTTON IN PLACE, WHICH WAS REPLACED WITH A NASAL FEEDING TUBE IN PLACE DIRECTLY INTO THE JEJUNUM, AND FINALLY REPLACED WITH THE MICRO G-JET DEVICE IN THIS REPORT. THE REPORTER INDICATED THAT THE CARDIAC DISEASE OF THE PATIENT MADE THEM MORE SUSCEPTIBLE TO PERFORATION OCCURRENCE, AND THEY DID NOT BELIEVE THAT THE TEAR WAS RELATED TO THE MICRO GJ DEVICE. THE TUBE PLACEMENT FOLLOWS THE GUIDEWIRE THAT IS PLACED PREVIOUSLY TO THE TUBE PLACEMENT, WHICH IS MOST LIKELY THE CAUSE FOR THE PERFORATION OCCURRENCE, AS WELL AS IN RELATION TO THE PATIENT CONDITIONS. HOWEVER, AS THE SMALL INTESTINE PERFORATION WAS FOUND DURING THE PLACEMENT OF THE MICRO G-JET DEVICE, AMT IS AIRING ON THE SIDE OF CAUTION IN REPORTING THE INJURY THROUGH THIS FDA REPORT. AMT REQUESTED THE DEVICE FOR RETURN TO ANALYZE, BUT THE DOCTOR INDICATED THAT THERE WERE NO MALFUNCTIONS OR OTHER DEVICE ISSUES, SO THEY LET THE DEVICE REMAIN WITH THE PATIENT AFTER THE PERFORATION WAS REPAIRED. THE LAST INFORMATION MADE AVAILABLE TO AMT REGARDING THIS CASE WAS THAT THE PATIENT WAS RECOVERING IN THE PICU WITH THE DEVICE.

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER, A GUIDEWIRE WAS USED TO ASSIST IN THE PLACEMENT OF A MICRO GJ DEVICE. IT WAS INDICATED THAT DURING A DEVICE PLACEMENT THERE WAS SOME FORCE TO GET THE GASTRIC PORTION OF THE TUBE THROUGH THE ABDOMINAL WALL. ONCE THE TUBE PLACEMENT WAS COMPLETE, IT WAS CHECKED UNDER FLUORO AND IT WAS NOTED THAT THERE WAS A PERFORATION IN THE SMALL BOWEL. TWO SURGEONS WERE ABLE TO REPAIR THE PERFORATION AND THE GJ DEVICE REMAINED IN PLACE AND THE PATIENT RECOVERED IN THE PICU. THE REPORTER HAD INDICATED THE CAUSE OF THE PERFORATION WAS RELATED TO OTHER PATIENT CONDITIONS AND FACTORS, INCLUDING CARDIAC DISEASE AND DYSPHAGIA, AS WELL AS A PREVIOUS TYPE OF TUBE THAT WAS IN PLACE PRIOR TO THE GJ DEVICE PLACEMENT. HOWEVER, AS THE PERFORATION WAS FOUND AFTER THE PLACEMENT PROCEDURE OF THE DEVICE IN QUESTION, THIS REPORT IS BEING REPORTED TO FDA OUT OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954582 MICRO G-JET TRANSGASTRIC-JEJUNAL FEEDING TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC. MGJ-1415-15 UNKNOWN 00842071124342

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Unknown Required Intervention