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

Catalog Number GJ-1620-30

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on the reported information, there was no death nor did this result in a 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.However, the malfunction of the device could lead to an adverse event if the malfunction were to recur.The laser lot number on the device assembly was 15105475.A device history review was completed and no anomalies were observed.Analysis of the returned device included a visual and functional evaluation.Examination determined that the returned device was very worn and discolored, with excessive growth and fungus throughout the length of the device.During our inspection, the entire distal end of the tubing was found clogged by a thick and solid brown substance.The tubing support was found detached and had partially migrated from the tubing and deformed.The tubing was found with adequate adhesive in the tubing support area.The failure of the device is not believed to be due to a manufacturing defect, but due to prolonged or harsh use.As the entire distal end of the tubing was clogged, preventing the tubing from being used, it is likely that excessive pressure was exerted on the tubing if clog removal was attempted.In addition, the clogged tubing would have prevented a guidewire from pushing through the device.It is also likely that the excessive substance build-up and fungus growth throughout the device weakened the device over time, allowing the tubing support to separate from the tubing.This type of failure has never been seen before and is considered an isolated event, not caused by a manufacturing defect.Additional information was requested and a follow up report will be submitted if we are able to obtain any of the requested information.(b)(4).

Event Description

The g-jet device was in use for about 2-3 months and the parents felt that it was plugged.Ir took an x-ray before removing it and thought it looked disrupted at the distal tip.They tried to thread a guidewire, but met resistance and couldn't thread it.When they pulled the tube out, it was discovered that the end of the tubing support had migrated and deformed.There was no reported harm of the patient.

• Brand Name: AMT G-JET
• Type of Device: LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer Contact: michelle scott ; 8006 katherine blvd; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 5780541
• MDR Text Key: 49132523
• Report Number: 1526012-2016-00013
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 07/09/2016

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: GJ-1620-30
• Device Lot Number: 16020283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1