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

Model Number ACE-1027

Device Problem Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

My son has had a cecostomy tube for many years, with no issues.We started using the amt miniace around a year ago with no problems.We routinely changed his amt miniace button on (b)(6) 2022.On (b)(6) 2022 the balloon failed.We had the same issue with 3 devices.I have repeatedly reached out to amt and sent the defective buttons to be analyzed.We have had recent similar issues with their gastrostomy buttons.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 complete their antegrade continence enema, 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 ace, ref ace-1027, lot 210927-236 10f 2.7cm, placed 7/2/2022 to 8/13/2022; amt mini ace, ref ace-1027, lot 220408-072 10f 2.7cm, placed 8/13/22 to 8/23/2022; amt mini ace, ref ace-1027, lot 220601-593 10f 2.7cm, placed 8/23/22 to 9/6/2022.Fda safety report id# (b)(4).

• Brand Name: AMT MINI ACE BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 15380673
• MDR Text Key: 299696789
• Report Number: MW5111929
• Device Sequence Number: 1
• 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
• Report Date: 09/06/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACE-1027
• Device Catalogue Number: ACE-1027
• Device Lot Number: 210927-236
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Patient Sequence Number: 1
• Treatment: CECOSTOMY.; HAS A GASTROSTOMY AND
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White