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 Problem Foreign Body In Patient (2687)

Event Type  malfunction  

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.

Event Description

The following was noted during a review of a scientific literature piece, "saunders tfc and osborne ms.A rare complication of nasal retaining loop insertion.Austin j otolaryngol.2015;2(4): 1038.".The information reported in the literature is as follows: "an (b)(6) man was referred by his gp with a 6 week history of foreign body sensation in his left nasal cavity caused by an unidentified metallic wire seen on anterior rhinoscopy.With a combination of radiology and flexible nasendoscopy the cause was found to be a flexible guidewire that had been used to insert a nasal retaining loop (nasal bridle) 12 months earlier.This required removal under general anaesthetic.Fortunately this retained foreign body resulted in no long term sequela to the nasal cavity.".

• Brand Name: AMT BRIDLE
• Type of Device: BRIDLE NASAL RETAINING SYSTEM
• 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: 11477553
• MDR Text Key: 254954724
• Report Number: 1526012-2021-00011
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 80 YR