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

Model Number	8229975
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Dyspnea (1816); Extubate (2402)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not cleared or sold in the us.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via manufacturer representative that the anesthetist referred that the patient did not breathe correctly after intubation during the procedure.The tube had a malfunction during a thyroid procedure.They have used the tube correctly and have checked the different parameters of the anesthesia workstation and decided to changed for another tube.The cuff was able to be inflated and the airway was established.The nurse had checked the cuff before intubation with the flex tube.This was the initial use for nerve intraoperative monitoring.They decided to change the tube.There was no delay in the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analysis of the device found that there was an occlusion of the main tube inside diameter at the proximal end near the inflation assembly connection with the main tube.The peak of the occlusion was approximately 100 degrees radially away from the inflation assembly and measured 4 inches long.The length spanned from the proximal side of the inflation assembly connection and proceeded distally.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 5mm.A syringe was used to fully deflate the cuff, there was 4cc of air removed.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 delaminated blocking almost the entire inside diameter.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: 7955912
• Report Number: 1045254-2018-00491
• Device Sequence Number: 203156
• 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
• Report Date (Section B): 12/11/2018

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: 11/19/2021
• Device Model Number: 8229975
• Device Catalogue Number: 8229975
• Device Lot Number: 0214434855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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: 60 YR