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

Model Number	MGJ-1412-10
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aspiration Pneumonitis (4455)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The original complaint was reported by the hospital on (b)(6) 2023.However, an indication of the pneumonia was not reported until on (b)(6) 2023, during a follow-up phone conversation with several nurses at the facility.Based on the provided information, the pneumonia occurred several days after the aspiration was originally noted on imaging.The nurse indicated that she was not certain whether the pneumonia event was related to the reported tubing failure, but amt is airing on the side of caution in reporting this event.The device was returned for inspection and the torn jejunal tube was confirmed in our analysis.The inner lumen support was still intact, so the entire device was able to be removed from the patient as intended.Inspection of the returned device and a review of the device history record did not find any manufacturing defect.It is believed that the failure is related to environmental related conditions and/or excessive pressure.Ongoing internal testing is planned in order to attempt to replicate the failure mode.A thorough review of production processes also found no steps that are believed to be related to the failure mode.The complaint information has been logged into our complaint database for trending purposes.Complaint#: (b)(4) was assigned to this report.
Event or Problem Description
Reporter indicated that within 7 days of placement, the patient returned to the hospital to have the gj device checked due to several vomiting events.X-ray imaging was performed for surveillance with possible aspiration noted.An inspection of the device found that the jejunal section of the tubing had torn at an unknown date, allowing feed intended for the jejunum to flow into the stomach.The tube was still partially attached and was able to be removed in full.Further conversation with nurse determined that patient was admitted for pneumonia several days later, though it was unknown if the cause was related to the device failure.

• Brand Name: AMT G-JET
• Common Device Name: LOW PROFILE TRANSGASTRIC JEJUNAL FEEDING TUBE DEVICE
• 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 ; 4407174252
• MDR Report Key: 17376060
• Report Number: 1526012-2023-00005
• Device Sequence Number: 6384472
• Product Code: KNT
• UDI-Device Identifier: 00842071124298
• UDI-Public: 00842071124298
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MGJ-1412-10
• Device Catalogue Number: MGJ-1412-10
• Device Lot Number: 201229-092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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
• Patient Sex: Unknown