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

Model Number	M1-5-1410-I
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Fever (1858); Peritonitis (2252)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once it was returned.The device was thoroughly tested for leakage with no leakage or other defects.The balloon was also inflated and left to sit for 24 hours with no leakage found.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaints from the 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.Complaint # (b)(4) was assigned to this report.Note that this record was originally identified as non-reportable as the returned device was found fully functional and not suspected to be the cause for the reported condition.However, a more recent review of the record determined that to air on the side of caution, a report should be sent to fda as the device cannot be definitively removed as a contributing cause to the patient's condition.However, it should be noted that the returned device was fully functional, so the reported occurrence is believed to be related to an undersized device, placement in a non-mature stoma, or improper inflation of the balloon.
Event or Problem Description
Per the original reporter, the balloon deflated after five (5) days of use and the patient presented with fevers and peritonitis, requiring an emergency laparotomy to repair the stomach and replace the gastric tube.The patient was then treated with 7 days of antibiotics and is now tolerating tube feeds.

• Brand Name: MINI ONE
• Common Device Name: LOW-PROFILE BALLOON BUTTON 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 18358613
• Report Number: 1526012-2023-00016
• Device Sequence Number: 7697380
• Product Code: KNT
• UDI-Device Identifier: 00842071113940
• UDI-Public: 00842071113940
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 230323-680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown