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

Model Number	GJ-1410-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Injury (2348); Bowel Perforation (2668)
Date of Event	09/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual device was not returned for evaluation, but a review of the device history record was performed and no anomalies were found.Amt agrees with the doctor's assessment that the jejunal perforation was caused by the patient's condition and the placement procedure, not the device itself.All information reasonably known at this time has been included in this report.Should additional information be obtained, a follow-up report will be provided.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to amt.We have assigned (b)(4) to this report.
Event or Problem Description
Based on the reported information from the doctor, the doctor was involved in an operation with a (b)(6) patient with down syndrome.The patient had many health factors at play, including duodenal atresia.The doctor went into the placement with knowledge that there was a high risk due to the patient's situation, but had decided that attempting the procedure was still the best option.The patient experienced a jejunal perforation from the placement procedure as confirmed by the radiologist.The radiologist involved with the case does not blame the amt device and only provided the information to amt for reporting purposes.Based on the doctor's analysis, he believes that the g-jet device did not cause the perforation and it was the patient's other factors that lead to the issues experienced from the placement procedure.

• Brand Name: AMT G-JET
• Common Device Name: TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 6945160
• Report Number: 1526012-2017-00008
• Device Sequence Number: 16366691
• Product Code: KNT
• UDI-Device Identifier: 00842071101381
• UDI-Public: (01)00842071101381(17)200501(10)170608-107
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/01/2020
• Device Model Number: GJ-1410-15
• Device Catalogue Number: GJ-1410-15
• Device Lot Number: 170608-107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: Death
• Patient Age: 6 WK
• Patient Weight: 4