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

Model Number	8229985
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Occlusion (1984); Extubate (2402)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 tube was routinely placed by the anesthesiologist prior to the thyroid procedure.The intubation was used normally without any problems.However, shortly before the patient was then placed in the operating room, there was an increase of the ventilation pressure.The ventilation pressure was noticed after the airway was established.So, the anesthesiologist decided to extubate the tube and intubate the patient again with another new tube.The delay time was only when the extubation and the new intubation of the tube.Then all was fine and the thyroid procedure was performed without any problems.There was no patient impact after the procedure as status of patient was alive with no injury.
Additional Manufacturer Narrative
Analysis of the device found that the flex circuit was cut off.In an as received condition, there was an occlusion of the main tube inside diameter which would have resulted in the reported event.It was at the proximal end near the inflation assembly connection with the main tube.The peak of the occlusion was approximately radially centered in respect to the inflation assembly and measured 2-1/8¿ inches long.The length spanned from the proximal side of the inflation assembly connection (by 5/8¿) and proceeded distally (by 1-5/8¿).The drawing requires that separation of the pvc layers (delamination) shall be less than or equal to 1.0mm (0.040¿).Using the 8.5mm inside diameter as reference, the delamination / separation of the pvc layer extended out from the surface by approximately 5.5mm.A syringe was used to inflate the cuff with 15cc of air.No pressure was applied to the cuff and within one minute, the inside diameter delamination increased to 7.5mm.The tube was deflated however the obstruction only partially receded.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8091032
• Report Number: 1045254-2018-00630
• Device Sequence Number: 13817701
• Product Code: ETN
• UDI-Device Identifier: 00643169358836
• UDI-Public: 00643169358836
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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: 01/31/2022
• Device Model Number: 8229985
• Device Catalogue Number: 8229985
• Device Lot Number: 0214833002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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 Weight: 78