MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT G-JET; LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE

Model Number	GJ-1415-15-I
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: AMT G-JET
• Common Device Name: LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 13486473
• Report Number: 1526012-2022-00001
• Device Sequence Number: 14576089
• Product Code: KNT
• UDI-Device Identifier: 00842071116750
• UDI-Public: (01)00842071116750(17)240601(10)210723-424
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2024
• Device Model Number: GJ-1415-15-I
• Device Catalogue Number: GJ-1415-15-I
• Device Lot Number: 210723-424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 14 MO
• Patient Sex: Unknown
• Patient Weight: 10 KG