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

Model Number	8229707
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned.However, the product analysis has not yet been performed.
Event or Problem Description
It was reported that during a right thyroid lobectomy, the endotracheal emg tube had gotten a hole in it and had to be replaced.Follow-up information provided indicates that there was no patient injury.However, when the initial incision was made by the surgeon, ¿gurgling¿ was heard by the anesthesiologist.An attempt was made to reinflate the balloon (cuff) without success.It would not hold air.Therefore, the tube was removed and replaced with a new tube.The case was finished without further incident.
Additional Manufacturer Narrative
The product analysis indicates that 1 opened sample of part number 8229707 from lot number 0212288555.A microscope and calipers were used to analyze the device.There was a residue consistent with biological contaminants and tape on the device.The electrode wires were cut off which is typical for handling purposes and is not related to the complaint.A syringe was used to inflate the cuff with 15cc of air and it leaked out immediately.Under magnification it was determined there was a ¿u¿ shaped puncture 0.3¿ from the proximal side of the cuff, 0.04¿ long, and on the interior of the main tube bend.There were abrasions leading up to the puncture and on the electrode contacts.Manufacturing is to perform a leak test during production.The ifu indicates that the user should test the cuff for leakage with 15cc to 20cc of air during preparation.Providing the instructions were followed, the issue would have been detected prior to intubation.However, the customer indicated the issue was detected during use.The information most likely indicates the damage occurred while handling and/or during intubation.
Additional Manufacturer Narrative
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: 6395149
• Report Number: 1045254-2017-00080
• Device Sequence Number: 10770822
• Product Code: ETN
• UDI-Device Identifier: 00643169060791
• UDI-Public: 00643169060791
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2017

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 Expiration Date: 11/09/2020
• Device Model Number: 8229707
• Device Catalogue Number: 8229707
• Device Lot Number: 0212288555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided; 03/13/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/07/2017; 10/02/2017
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 127