MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229736
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the endotracheal tube kinked (folded) after the mouth and the patient became blue.The ventilation was not correct during a part of the intervention.
Additional Manufacturer Narrative
The customer reported the part number was 8229736 which is a 6mm tube, the device received was part number 8229737 which is a 7mm tube based off the printing.Since the reported part number is not what was received, the lot number is not valid for the part received.There was a residue consistent with biological contaminants and tape on the device.The electrode wires were cut off when received however this is typical for handling purposes and is not related to the complaint.Analysis found that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.There were no kinks in the tube or evidence the tube was kinked at any point.There was no obstruction of the inside diameter of the tube (the ventilation path).Visually; the murphy eye and the distal end bevel were orientated 90 degrees away from the midline which is required per the drawing.The cuff was inflated and deflated five times with no issue.Functionally; pressure was applied to the center of the tube while holding both ends of a returned sample and another reserve sample 7mm tube; the force required to straighten the designed curvature of the tube was 1.0lb for the returned sample and 1.1lb for the reserve sample.There was no significant difference in the rigidity of the tubes.The inside diameter of the tube measured 7.24mm which is within specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8086544
• Report Number: 1045254-2018-00610
• Device Sequence Number: 19227323
• Product Code: ETN
• UDI-Device Identifier: 00643169782631
• UDI-Public: 00643169782631
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8229736
• Device Catalogue Number: 8229736
• Device Lot Number: 0215058858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening