MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT IP DILATOR SET

Model Number	IP-DIL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Stomach Ulceration (4488)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The original reporter indicated that the patient experienced a perforation through the posterior gastric wall.Reported that the procedure lasted 5-10 minutes for g-tube insertion.The patient experienced septic shock and need for return to the or.Abdominal compartment syndrome necessitating multiple trips to the or.
Additional Manufacturer Narrative
Based on the reported information, it was determined that an adverse event should be reported to fda as a stomach perforation was reported after placement of a gastrostomy tube.This was reported while using the ip-dil kit, which includes accessories for device placement.The reporter indicated that the guidewire in the kit caused the perforation to occur.No device has been returned for examination.Discussion with an internal health professional concluded that the guidewire end would not be strong enough to perforate the stomach lining, as it is extremely floppy.It is more likely that the dilator was inserted too deep into the stomach during dilation and caused the perforation to occur.Amt requested the device for return to analyze, but there has been no confirmation of the device being available for return at this time.The complaint has been logged into our system under report #: 20240112.We will update this report accordingly if additional information is received and that information changes the outcome of the documented conclusion.

• Brand Name: AMT IP DILATOR SET
• Common Device Name: AMT IP DILATOR SET
• 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: 18859465
• Report Number: 1526012-2024-00004
• Device Sequence Number: 15524371
• Product Code: KNT
• UDI-Device Identifier: 00842071131876
• UDI-Public: 00842071131876
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K073034
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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
• Device Model Number: IP-DIL
• Device Catalogue Number: IP-DIL
• Device Lot Number: 240111-615
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Sex: Unknown