MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINI ONE BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 1M-5-14-20

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

My son has had a gastrostomy tube for many years, with no issues.We routinely changed his amt minione balloon button on (b)(6) 2022.On (b)(6) 2022 the balloon failed.We had the same issue with 6 devices until (b)(6) 2022 when the button was changed to a non-balloon button due to repeat balloon failures.I repeatedly reached out to amt and sent the defective buttons to be analyzed.They said the issue was we were putting a foreign substance into the valve to fill the balloon.We have never instilled any substance inside the balloon port except for water to fill the balloon.When i questioned if the substance in the port could be from when we checked the balloon for water and pulled back on the syringe in the balloon port.Their response was, "it is certainly a possibility that substance could be pulled back into the valve when pulling back on the syringe, though only after the balloon has failed.Often though when the balloon bursts the device also comes out of the stoma, so you wouldn't expect to find residue in the valve area, especially on multiple devices." out of an abundance of caution, we also had the button resized and used a large sized button, with the same results.Ultimately, my son had to have the device completely replaced with a non-balloon button.There is no reason this many buttons should fail with no clear reason.We are not the only family having this issue.This needs to be investigated.It is a serious issue when the balloons fail because the buttons can become dislodged, it effects the ability for the individual to receive feeds, it can cause trauma to the site if the stoma shrinks and needs to be dilated to replace the failed button.Not to mention the cost to continue to replace these medically necessary devices, that should ideally last 3 to 6 months.The lots we had balloon failures in are: amt mini one, ref 1m-5-14-20, lot 220407-376 14f 2.0cm, placed 5/29/2022 to 6/10/2022, amt mini one, ref 1m-5-14-20, lot 210715-162 14f 2.0cm, placed 6/10/2022 to 6/21/2022 amt mini one, ref 1m-5-14-20, lot 220524-558 14f 2.0cm, placed 7/5/2022 to 7/11/2022 amt mini one ref 1m-5-14-23, lot 220607-383 14f 2.3cm, placed 6/23/2022 to 7/5/2022 amt mini one ref sm1-5-1423, lot 220622-579 14f 2.3cm, placed 7/2/22 to 7/30/2022 amt mini one ref sm1-5-1423 lot 220622-579 14f 2.3cm, placed 7/30/22 to 8/4/2022.

• Brand Name: AMT MINI ONE BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 15380629
• MDR Text Key: 299680774
• Report Number: MW5111926
• Device Sequence Number: 3
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1M-5-14-20
• Device Lot Number: 220524-558
• Patient Sequence Number: 1
• Treatment: HAS GASTROSTOMY AND CECOSTOMY TUBE
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White