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

Model Number	8229975
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code 510k: device not marketed in the us; similar device available.Product evaluation: analysis results not available; device has been received internationally and forwarded to xomed, 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
Prior to intubating the patient for a total thyroidectomy, the physician tested the tube for patency; the tube performed as expected.The physician reported using less than 10 ml of air to inflate the cuff when intubating the patient.Twenty minutes after starting the surgery there was an airway pressure increase.After several minutes investigating the source of the problem the anaesthesiologist discovered that the source of the problem was blockage of the inner lumen.For this reason the tube was changed for a new one.There was no patient injury.
Additional Manufacturer Narrative
The device was received for analysis.Visually, there was no blockage of the inside diameter of the main tube in an as received condition.A syringe was used to inflate the cuff with 10cc of air.In less than 30 seconds the inside diameter began to delaminate and block the airway path which would have resulted in the reported event.The drawing requires that separation of the pvc layers (delamination) shall be less than or equal to 1.0mm (0.040¿).Using the 7.5mm inside diameter as reference, the delamination / separation of the pvc layer measured approximately 3.2mm (0.126¿ or 50% 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.Slight pressure was applied to the cuff while inflated and the occlusion proceeded to block approximately 90% of the inside diameter.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.
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: 6545692
• Report Number: 1045254-2017-00141
• Device Sequence Number: 16427665
• Product Code: ETN
• UDI-Device Identifier: 20643169358816
• UDI-Public: 20643169358816
• 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,Followup
• Report Date (Section B): 04/11/2017

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: 09/28/2020
• Device Model Number: 8229975
• Device Catalogue Number: 8229975
• Device Lot Number: 0212036550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/01/2017; 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: 37 YR
• Patient Weight: 60