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

Model Number	8229965
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Airway Obstruction (1699); Extubate (2402)
Date of Event	09/04/2019
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 provider (hcp) reported via a distributor that the anesthesiologist intubated the patient with stimulation cannula which was delivered at the facility a day before.After approximately 30 minutes, overall anesthesia in the patient decreased respiratory volume and increased airway pressure.During the inspection of the tube, it was found that the inner lumen of the cannula was obstructed at a distance of 26-28 cm.The patient was then re-intubated with a new tube.After performing the visual inspection, it was found that when inflating the cannula cuff, the inner lumen of the cannula separates the inner lining of the cannula, creating a bulge preventing ventilation of the patient as it completely obstructs the tube.The procedure was completed using a back-up device.The patient was alive with no injury.
Additional Manufacturer Narrative
Analysis found that visually, there was no obstruction of the inside diameter of the main tube when received.A syringe was used to inflate the cuff with 15cc.Immediately the inside diameter delaminated blocking most of the airway path which would have resulted in the reported event.The delamination / separation of the pvc layer shall be equal to, or less than 1.0mm (0.040¿), and the actual extended out from the surface and touched the other side (approximately 6.5mm) which is out of specification.The delamination occurred without pressure applied to the cuff.The approximate location of the occlusion on the inside diameter corresponded to where the inflation assembly attaches to the main tube.Deflation of the cuff caused the obstruction to recede.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: 9191046
• Report Number: 1045254-2019-00514
• Device Sequence Number: 19454494
• Product Code: ETN
• UDI-Device Identifier: 00643169358799
• UDI-Public: 00643169358799
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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): 11/19/2019

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: 01/31/2022
• Device Model Number: 8229965
• Device Catalogue Number: 8229965
• Device Lot Number: 0214833003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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