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

Model Number	MGJ-1415-15
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the original reporter, a guidewire was used to assist in the placement of a micro gj device.It was indicated that during a device placement there was some force to get the gastric portion of the tube through the abdominal wall.Once the tube placement was complete, it was checked under fluoro and it was noted that there was a perforation in the small bowel.Two surgeons were able to repair the perforation and the gj device remained in place and the patient recovered in the picu.The reporter had indicated the cause of the perforation was related to other patient conditions and factors, including cardiac disease and dysphagia, as well as a previous type of tube that was in place prior to the gj device placement.However, as the perforation was found after the placement procedure of the device in question, this report is being reported to fda out of caution.
Additional Manufacturer Narrative
Based on the reported information, it was determined on that an adverse event should be reported to fda as a jejunal perforation was found in the small intestines of the patient 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 regarding the perforation was that it was not related to the micro g-jet device.The patient had previously had a gastric button in place, which was replaced with a nasal feeding tube in place directly into the jejunum, and finally replaced with the micro g-jet device in this report.The reporter indicated that the cardiac disease of the patient made them more susceptible to perforation occurrence, and they did not believe that the tear was 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, as well as in relation to the patient conditions.However, as the small intestine perforation was found during the placement of the micro g-jet device, amt is airing on the side of caution in reporting the injury through this fda report.Amt requested the device for return to analyze, but the doctor indicated that there were no malfunctions or other device issues, so they let the device remain with the patient after the perforation was repaired.The last information made available to amt regarding this case was that the patient was recovering in the picu with the device.

• Brand Name: MICRO G-JET
• Common Device Name: 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: 14364955
• Report Number: 1526012-2022-00007
• Device Sequence Number: 11258166
• Product Code: KNT
• UDI-Device Identifier: 00842071124342
• UDI-Public: 00842071124342
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: MGJ-1415-15
• Device Catalogue Number: MGJ-1415-15
• Device Lot Number: UNKNOWN
• 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: 04/11/2022
• Initial Report FDA Received Date: 05/11/2022
• 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: Required Intervention
• Patient Age: 9 MO
• Patient Sex: Unknown
• Patient Weight: 9 KG