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

Catalog Number 4-4106M

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problems Erosion (1750); Tissue Damage (2104); Blood Loss (2597)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

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.However, intervention was required to remove the device from the patient's nasal tissue.This was a minor injury and no patient complications resulted from this event.The device was discarded after use and was not available for evaluation.The lot number was requested, but not available and a device history review for the lot number could not be performed.A review of our complaint records found that only one similar complaint has been reported to amt in 2013 with no serious injuries noted.While intervention was required to remove the umbilical tape from the patient's nose, no serious injury occurred in both of the cases reported to amt and the overall risk to a patient is considered to be low.It is believed that the patient anatomy and or condition is what contributed to the reported incident and not the design of the device due to the low occurrence rate of this type of incident.We have assigned complaint number (b)(4) to this report.

Event Description

Patient had difficulty with initial placement and when they went to remove the bridle 3 weeks later it had adhered to the tissue requiring multiple removal attempts and nasal irrigation.Ultimately, removal resulted in epistaxis.

• Brand Name: AMT MICRO BRIDLE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer Contact: michelle scott ; 8006 katherine blvd; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 5670924
• MDR Text Key: 45645290
• Report Number: 1526012-2016-00008
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2016

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 Catalogue Number: 4-4106M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 13 MO
• Patient Weight: 7