MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. G-JET; TRADITIONAL LENGTH TRANSGASTRIC JEJUNAL FEEDING TUBE

Model Number	TGJ-18-45
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon removal of the device the enclosed tubing support had partially dislodged from the tube and there was a noticeable tear in the center of the tube where the tubing support was secured.There was no record of harm to the patient provided.Amt has been working with the customer to obtain additional information regarding what triggered the initial need for the removal of the device to better understand how the failure occurred.A device history review was conducted and no similar complaints have been logged from the same batch or any other batches of the same device type.Based on the provided information, there was no evidence found that would indicate the failure was due to a manufacturing defect or quality issue.The device was in use for nearly 4.5 months before the failure occurred, indicating that the device was properly functioning during this time.We have assigned complaint # (b)(4) to this report and will provide additional information to the fda if additional information is able to be obtained and it changes the conclusion of this report.
Event or Problem Description
Imaging over the abdomen demonstrated apparent fracturing of the gj tube.Contrast was injected through the tube demonstrating complete fracturing of the gj tube near the gastric lumen with complete discontinuity of the jejunal portion of the catheter.A.035 stiff glidewire was advanced through the catheter into the stomach.The gastric portion of the tube was removed.The distal jejenal portion was retained inside the patient and was connected to the proximal gastric portion via a metallic spring coil.Attempt was made to pull the distal portion out via the coil, however this cause significant pain for the patient.After further discussion, dr.Of gi was consulted.The decision was made to have the retained portion of the catheter removed endoscopically by gi.The metallic spring coil was cut with scissors, and the external portion taped to the patient's skin.

• Brand Name: G-JET
• Common Device Name: TRADITIONAL LENGTH TRANSGASTRIC JEJUNAL FEEDING TUBE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 11598945
• Report Number: 1526012-2021-00012
• Device Sequence Number: 3496700
• Product Code: KNT
• UDI-Device Identifier: 00842071125318
• UDI-Public: (01)00842071125318(17)230501(10)201002-304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: TGJ-18-45
• Device Catalogue Number: TGJ-18-45
• Device Lot Number: 201002-304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention