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

Model Number	M1-5-1410-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf/importer report #: (b)(4), "gastrostomy tube balloon broke during inflation, trocar.Portion of trocar broke off during use.Patient admitted for laparoscopic g tube.When using elbow items, an orange piece broke off trocar.Item retrieved and the button on the g-tube broke off.Item retrieved.No harm to patient.Items given to purchasing manager [redacted name] for review with company.5mm trocar ref# ms100705, lot #p3e0261.Gastric button g tube ref# m1-5-1410-i, lot #221210-042.".
Additional Manufacturer Narrative
This report is a response to mdr report # (b)(4) which was received from fda by amt on 10/10/2023.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 device returned.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaints from other users regarding tears or ruptures from these same batches.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.Complaint # (b)(4) was assigned to this report.

• Brand Name: MINI ONE
• Common Device Name: LOW-PROFILE BALLOON GASTROSTOMY BUTTON
• 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 18065491
• Report Number: 1526012-2023-00012
• Device Sequence Number: 20754185
• Product Code: KNT
• UDI-Device Identifier: 00842071113940
• UDI-Public: 00842071113940
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 221210-042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (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: 1 MO
• Patient Sex: Female
• Patient Race: White