MAUDE Adverse Event Report: NUVASIVE NUVASIVE EMG ENDOTRACHEAL TUBE; NEUROSURGICAL NERVE LOCATOR

Model Number	2010770
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.At this time alleged event could not be confirmed.Labeling review: warnings, cautions and precautions: ".Over-inflation of the cuff may cause cuff failure and subsequent tracheal damage.Cuff failure may potentially cause the cuff to deflate or herniate and block the tube airway." ".Confirm the inner diameter of the tube is unblocked after test inflation." method of use: ".Determine the size of the tube for the patient prior to intubation.Test the cuff for leakage with 15cc to 20cc of air prior to intubation of the patient.Confirm the cuff is fully deflated prior to intubation of the patient.".
Event or Problem Description
It was reported during procedure cuff deflated causing procedure stop.Tube was re-inflated and procedure continued as planned.No patient harm reported.
Event or Problem Description
Supplemental report, updated data in fields.
Additional Manufacturer Narrative
The product was returned to nuvasive for examination where no product malfunction could be identified.When properly handled, the tube cuff inflated without leaks and held for two hours.Testing and interviews with end user were able to identify and confirmed that the deflation cap was reattached to the valve assembly post inflation which releases the cuff pressure as designed.The nurse practitioner and neurophysiologist were given feedback on the identified root cause.No patient injury has been reported.

• Brand Name: NUVASIVE EMG ENDOTRACHEAL TUBE
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9339128
• Report Number: 2031966-2019-00252
• Device Sequence Number: 1927274
• Product Code: PDQ
• UDI-Device Identifier: 00887517055637
• UDI-Public: 887517055637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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 Model Number: 2010770
• Device Lot Number: 1817608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: Hospitalization
• Patient Age: 65 YR