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

Model Number	8229970
Medical Device Problem Codes	Partial Blockage (1065); Use of Device Problem (1670); Fitting Problem (2183)
Health Effect - Clinical Codes	Airway Obstruction (1699); Extubate (2402)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative that the tube did not work properly during a procedure.The hcp mentioned that it seemed that the balloon was loose.After 20 minutes, the tube started to obturate and the inner lumen was closed under pressure of the balloon.After 30 minutes, the tube was changed since the patient was not ventilated.
Additional Manufacturer Narrative
(b)(6).Analysis found that in an as received condition the inflation assembly was cut off therefore the cuff was deflated, and there was no occlusion of the main tube inside diameter.The inflation assembly was likely cut off for handling purposes.A syringe was placed over the portion of the inflation assembly remaining, air was injected, and forceps were used to pinch the tube to prevent the air from escaping.Mild pressure was applied to the cuff and immediately the inside diameter delaminated blocking most of the airway path.The drawing requires that separation of the pvc layers (delamination) shall be less than or equal to 1.0mm (0.040¿).Using the 7.0mm inside diameter as reference, the delamination / separation of the pvc layer extended out from the surface by approximately 7mm which is out of specification.The approximate location / orientation of the occlusion on the inside diameter began under the cuff and proceeded distally ¼¿ beyond the cuff, and the peak was approximately centered about the inflation lumen.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the distributor reported via a manufacturer representative that the event occurred during a thyroidectomy procedure.The case was completed after reintubation of the patient.There was no delay in the procedure.

• 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: 8073528
• Report Number: 1045254-2018-00599
• Device Sequence Number: 16709676
• Product Code: ETN
• UDI-Device Identifier: 00643169358805
• UDI-Public: 00643169358805
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 02/04/2022
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0214857736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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: Other