MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE PRO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number E4-4218

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

This report is a response to user facility report #(b)(4).Based on the provided information, the reported incident was not caused by a manufacturing defect.The device functioned as intended and there was no malfunction as defined by the fda.Limited information was provided to amt regarding the injury that was caused to the patient.It was reported that the septum of the patient was pulled out and intervention was required.Amt has made multiple attempts to obtain clarifying information regarding how the device was placed, how placement was verified, imaging of the placement procedure, and other information.The original reporter has not provided any additional information regarding the reported case after multiple follow-up attempts.Based on the limited information available, it is believed that the device was improperly placed and was not placed around the vomer bone as required in the product instructions.We will continue to work with the original reporter to obtain additional information.We have assigned complaint# (b)(4) to this report and will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.

Event Description

Per the original reporter in medwatch report #: (b)(4)."the patient pulled his ngt out with the bridle and tore his septum.He's had multiple procedures to control the bleeding and this last time ended up again in icu intubated.".

• Brand Name: AMT BRIDLE PRO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 12755321
• MDR Text Key: 284452182
• Report Number: 1526012-2021-00019
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071118112
• UDI-Public: (01)00842071118112(17)240501(10)210511-305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/01/2024
• Device Model Number: E4-4218
• Device Catalogue Number: E4-4218, 4-4218
• Device Lot Number: 210511-305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR
• Patient Sex: Male