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

Model Number	GJ-1415-15-I
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # mw5102495 which was received by amt from the fda on 08/16/2021.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt confirmed with the device referenced in the report is not available for return.Since the device was not returned, a visual and functional evaluation could not be performed and device failure cannot be confirmed at this time.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaint reports for this same batch.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
Per the original reporter's report #: mw5102495, it was reported "to ir (b)(6) 2021 for gastrojejunostomy catheter check and exchange.Shortly later (noted less than one hour), it was discovered the balloon of the tube had ruptured and pt.Had to return to ir suite for gastrojejunostomy catheter check and exchange noting the catheter was faulty.Fda safety report id# (b)(4).".

• Brand Name: AMT G-JET LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Common Device Name: TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 12468927
• Report Number: 1526012-2021-00017
• Device Sequence Number: 5146817
• Product Code: KNT
• UDI-Device Identifier: 00842071101480
• UDI-Public: (01)00842071101480(17)240201(10)210329-235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/14/2021

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: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: GJ-1415-15-I
• Device Catalogue Number: GJ-1415-15-I
• Device Lot Number: 210329-235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1