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

Model Number 4-XXXX

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

Patient Problems Emotional Changes (1831); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

This report is a response to an event found in an internal literature review.We have assigned complaint # (b)(4) to this report.Based on the reported information, there was no death nor did this result in permanent impairment or a serious injury that is life-threatening, as defined by the fda.Although there was no patient harm in this case and there is no chance of death or serious injury, additional intervention was required, thus this record is being reported.Amt is working on contacting the initial reporter to see if the device is available for examination.We 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

The following information was found documented in the following article inayat f, ur rahman a, almas t, et al.(may 28, 2020) nasal bridles for securing nasoenteric feeding tubes: a review of clinical effectiveness and potential complications.Cureus 12(5): e8325.Doi 10.7759/cureus.8325.The occurrence reported the following: "a (b)(6)-year-old female underwent an uneventful simultaneous liver-kidney transplantation 10 days prior to the current presentation.Her medical history included steatohepatitis-related cirrhosis and chronic renal insufficiency following diabetic nephropathy.Owing to her significant baseline frailty, the patient showed a prolonged postoperative recovery.She continued to have a poor appetite and fluctuating mentation after the surgery.A nasoenteric tube was thus placed through the left nostril to ameliorate the caloric deficit.After the procedure, magnetic nasal bridle (amt bridle, applied medical technology, brecksville, oh, usa) insertion was attempted.However, she became extremely agitated during the bridle placement and intermagnetic linkage could not be achieved.Upon removal of the probe, it was noted that the magnet was missing from its distal end.The otorhinolaryngology service was consulted.An urgent nasal endoscopy was performed, but the magnet could not be visualized.A plain radiograph of the paranasal sinuses showed a radiopaque object lodged at the sphenoid os.A multidisciplinary team planned a ct-guided endoscopic sinus surgery.The surgical intervention resulted in the successful retrieval of the magnet.Thereafter, she completely recovered without the need for a percutaneous gastrostomy tube (peg) placement".

• 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: 11477459
• MDR Text Key: 242228880
• Report Number: 1526012-2021-00008
• Device Sequence Number: 1
• Product Code: KNT
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-XXXX
• Device Catalogue Number: 4-XXXX
• Device Lot Number: UNKNOWN
• 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: 66 YR