MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE; BRIDLE NASAL RETAINING SYSTEM

Model Number 4-41XX

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

The following was noted during a review of a scientific literature piece, titled "retained nasal tube bridle system insertion stylet presenting as nasal foreign body: a report of two cases., ryan s.Jackson, md, saurabh sharma, md".Note that the patient was evaluated between 8/2012 and 8/2013.The information reported in the literature is as follows: "the second case was a (b)(6) year-old male that presented to the emergency department for nasal congestion and pain.He also had a prolonged hospitalization requiring intubation for 8 days and nasal feeding tube insertion.A nasal bridle kit was used to help secure the feeding tube placement.Once extubated, he was tolerating an oral diet and the feeding tube was removed.He was discharged to a long-term nursing facility and returned to the emergency department later that day complaining of nasal pain and possible foreign body.On anterior rhinoscopy with a nasal speculum, the patient was noted to have an orange foreign body within the left nasal cavity that was easily identified as a stylet used in the nasal bridle system.This was removed without difficulty using a pair of forceps to grab onto the head of the stylet at the bedside and the patient was transferred back to his nursing facility without any complications.".

Manufacturer Narrative

Based on a review of the information, 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.However, due to the improper use of the device, intervention was required to remove the stylet from the patient's nares.The device was not returned for inspection, so an analysis of the device could not be performed.The condition caused by the device was the result of not following the directions for use.The following in an excerpt from the bridle directions for use: ·it may be necessary to advance or manipulate the probe to achieve magnet contact.·remove stylet after magnet connection.·if necessary, gently twist the probes from side to side and/or up and down to encourage contact between the magnets.If no contact has occurred, then advance both the white catheter and the blue probe.Important: once contact has occurred, remove the orange stylet completely from the white catheter and dispose.Based on a review of the information, the device was used improperly and dangerously, and the directions for use were not followed.The device did not malfunction.The excerpt from the directions of use above shows that the instructions call for the removal of the stylet after magnet connection.A second (highlighted) instruction is included to call to the importance in removing the orange stylet and disposing the component.The user of the device did not follow the directions for use, and pulled the stylet and orange handle through the patient's nose.The medwatch form also states that "after review of the event, we believe that this is a use issue." in addition, a dhr review showed no anomalies.Nor was the amt device returned to amt for analysis.Amt will provide additional information to the fda when/if the device is able to be retrieved and analysis of the device changes the conclusion of this report.

• Brand Name: AMT BRIDLE
• Type of Device: BRIDLE NASAL RETAINING SYSTEM
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 11477519
• MDR Text Key: 280462372
• Report Number: 1526012-2021-00010
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 03/12/2021

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 Operator: Health Professional
• Device Model Number: 4-41XX
• Device Catalogue Number: 4-41XX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR