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

Model Number	MGJ-1410-10-I
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the reported information, it was determined that an adverse event should be reported to fda as a duodenum perforation was found in the small intestines of the patient three days 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 indicated that the patient only weighed 3kg.The instructions of use for the device calls out that the device is only indicated for patients over 6kg.Therefore, the device was placed in a patient outside of the indicated size range.Amt requested the device for examination, but it was determined that the device had been discarded and would not be returned.It is not believed that the perforation is 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.Amt complaint #: (b)(4) was logged to document this complaint.
Event or Problem Description
Reported that surgery was performed on a 3kg patient to place the device on (b)(6) 2023.A perforation of the duodenum was noted on (b)(6) 2023.The device was removed from the patient and was discarded.

• Brand Name: MICRO GJ
• 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 ; 4407174000
• MDR Report Key: 17620894
• Report Number: 1526012-2023-00006
• Device Sequence Number: 20658525
• Product Code: KNT
• UDI-Device Identifier: 00842071124731
• UDI-Public: 00842071124731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MGJ-1410-10-I
• Device Catalogue Number: MGJ-1410-10-I
• Device Lot Number: 230621-347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Male
• Patient Weight: 3 KG