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

Model Number	8229980
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not marketed in the u.S; similar device available.Product evaluation: analysis results are not available; the device has been forwarded from international site, not yet received.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
When preparing for a thyroidectomy, the anesthesiologist tested the nim flex emg tube for patency; it worked as expected.The patient was intubated with the emg tube in the induction room prior to surgical incision; 5-7 ml of air was used to inflate the cuff, and pressure reading of the cuff measured with a manometer read 30 mbar.¿for anesthesia usual narcotics were used, no problems occurred during intubation of the tube.Then they blocked [checked] the tube on both sides the same breath sounds, but it sounds not well.The team relocked [deflated and inflated] the tube and they try to find out was wrong.First the team was thinking about problems with the narcotics.But after unlocking [deflating] the status of the patient was better.They blocked [inflated] again and got wrong breath sounds again.¿ they then used a laryngoscopy system to see if there were problems within the tube.The team saw that the inside lumen of the tube was blocked.They then ¿decided to change the tube; no more problems occurred.The patient was oxygenated the whole time, so there are no negative consequences for the patient.¿.
Additional Manufacturer Narrative
Product evaluation: 1 opened sample part number 8229980, from lot number 0212660127, 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 15cc 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 of tube ¿blocked¿.Using the 8.0mm inside diameter as reference, the delamination / separation of the pvc layer measured approximately 6.2mm (or 75% occlusion) 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 and measured approximately 1-1/2¿ long.The tube was deflated and the obstruction receded.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6629576
• Report Number: 1045254-2017-00181
• Device Sequence Number: 19071091
• Product Code: ETN
• UDI-Device Identifier: 20643169358823
• UDI-Public: 20643169358823
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2017

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: 01/22/2021
• Device Model Number: 8229980
• Device Catalogue Number: 8229980
• Device Lot Number: 0212660127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/14/2017; 06/14/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/07/2017; 09/07/2017
• 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: 42 YR
• Patient Weight: 64