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 Codes	Respiratory Distress (2045); Extubate (2402); Low Oxygen Saturation (2477)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis found that there was an occlusion of the main tube inside diameter at the distal end near the cuff.A syringe was used to inflate the cuff with 15cc of air.No pressure was applied to the cuff and the inside diameter delaminate immediately blocking almost the entire inside diameter.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 6.5mm which is out of specification.The approximate location / orientation of the occlusion on the inside diameter was under the entire cuff extending past its distal edge and almost 90 degrees out from the inflation lumen.The tube was deflated however the obstruction only partially receded.Additionally, there was a residue consistent with biological contaminants and tape adhesive on the device.The electrode wires were cut off which is typical for handling purposes and there was some wrinkling of the flex circuit as well.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 during the incision, there was suddenly respiratory hyper pressure and impossibility of ventilation.Strong desaturation was applied and the surgery was stopped immediately.There was extubation on (b)(6) and reventilation with mask, re-saturation and re-intubation on eiscman.In conclusion and after checking, the tube had an intraluminal hernia when inflating balloon.This prevented any ventilation.Patient was alive-no injury.There was no patient impact.

• 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: 8048086
• Report Number: 1045254-2018-00571
• Device Sequence Number: 13849499
• Product Code: ETN
• UDI-Device Identifier: 00643169358812
• UDI-Public: 00643169358812
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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: 03/12/2022
• Device Model Number: 8229975
• Device Catalogue Number: 8229975
• Device Lot Number: 0215068870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/07/2018
• 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: Life Threatening
• Patient Weight: 100