MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE® BALLOON BUTTON; LOW PROFILE GASTROSTOMY FEEDING TUBE

Model Number	M1-5-1208-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medsun report # (b)(4) which was received by amt from the fda on 08/08/2024.Within this report, it was noted that this was the second incident of a device failure of this nature for the patient.Two occurrences were originally reported to amt on 07/08/2024 by the same initial reporter, and one device was returned for evaluation.It was reported that these devices were in use for 14-15 days, while the information marked in the medsun report stated the device was in use for 1 day.For reporting purposes, the device life of 1 day, occurrence date of june 2024, and awareness date of 08/08/2024 were reported in this form.On all accounts, it was reported that the device was replaced, and that no patient injury occurred.It is believed that the device returned to amt on 07/15/2024 is the same device referenced in the medsun report.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no 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.Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.A tear in the balloon wall was identified on the returned device.A device history review was completed for the device lot number and no anomalies were found and there have been no other complaints from other users regarding balloon tears or ruptures from this same batch.Recent trending data shows no anomalies in reported failures from the field.The complaint information has been logged into our complaint database for trending purposes.Reporting information can be found under complaint # (b)(4).Information regarding device investigation can be found under complaint # (b)(4).
Event or Problem Description
It was reported that a, "12 fr gt balloon damaged and leaking.Surgical team to bedside and replaced gastronomy tube (gt).Follow-up imaging requiring transporting patient to x-ray for imaging studies needed.G-t saved in biohazard bag and placed in defective product bin.This is the second incidence of something like this happening for this patient's gt".

• Brand Name: MINI ONE® BALLOON BUTTON
• Common Device Name: LOW PROFILE GASTROSTOMY 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: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 20135960
• Report Number: 1526012-2024-00010
• Device Sequence Number: 17884719
• Product Code: KNT
• UDI-Device Identifier: 00842071113810
• UDI-Public: 00842071113810
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K945618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: M1-5-1208-I
• Device Catalogue Number: M1-5-1208-I
• Device Lot Number: 230317-445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 6 MO
• Patient Sex: Female