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

Model Number	8229970
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Respiratory Distress (2045); Extubate (2402)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not marketed in the us; similar device available.Product evaluation: analysis results are not available; device being shipped from (b)(4) to us.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The anesthetist reported that the tube and cuff were checked for patency prior to intubating the patient with the nim flex emg tube for a thyroidectomy.Approximately 30-40 minutes into the procedure the anesthesiologist noted that "the patient doesn't breathe correctly".Saturation, shallow breathing and other parameters were checked; a decision was made to reintubate the patient with a new tube to complete the procedure.There was no reported injury; the procedure was successfully completed.
Additional Manufacturer Narrative
Product evaluation: 1 opened sample, part number 8229970, from lot number 0213860170, was received for analysis.In an as received condition there was no occlusion of the main tube inside diameter.A syringe was used to inflate the cuff with 15 cc of air.Mild pressure was applied to simulate intubation and in less than 15 seconds the inside diameter began to delaminate and block the airway path which would have resulted in the reported event.Using the 7.0 mm inside diameter as reference, the delamination / separation of the pvc layer measured over 5.5 mm from the wall which is out of specification.The approximate location / orientation of the occlusion on the inside diameter was centered around the inflation assembly.The tube was deflated with no issue, and the obstruction 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 north; jacksonville FL 32216
• MDR Report Key: 7137813
• Report Number: 1045254-2017-00472
• Device Sequence Number: 19058175
• Product Code: ETN
• UDI-Device Identifier: 20643169358809
• UDI-Public: 20643169358809
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0213860170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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 Age: 42 YR
• Patient Weight: 60