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

Model Number	8229738
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: analysis results are not available; device has been sent to ous offices and is to be forwarded to xomed for analysis once received.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that prior to intubating the patient for a total thyroidectomy the emg cuff and tube were both checked for patency; they both worked as expected.About 5 minutes after intubating the patient with the trivantage emg tube, the anesthesiologist observed that the cuff was slowly leaking air.The patient was extubated and reintubated with a new tube to complete the procedure; there was no patient injury.
Additional Manufacturer Narrative
Product evaluation: 1 opened sample, part number 8229738, from lot number 0212755672 was received for analysis; there was a residue consistent with biological contaminants on the device.Based off the reported event, it is likely that any damage to the tube occurred during intubation or sometime thereafter.The cuff was inflated with 20 cc of air and it leaked out immediately which would have resulted in the reported event.When viewed under magnification, the cuff had an ¿l¿ shaped puncture in it measuring 0.04¿ x 0.05¿.There was no damage to the packaging that would indicate a cause for the observed damage.The observed defect would have been detected during an inflation test if present at the time of the test.The instructions for use indicates that damage may occur to the device during actions such as; over inflation, insertion of objects, and biting forces.The information likely indicates that the cuff was damaged during, or after intubation due to a handling issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6999137
• Report Number: 1045254-2017-00395
• Device Sequence Number: 13916181
• Product Code: ETN
• UDI-Device Identifier: 20643169782659
• UDI-Public: 20643169782659
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112686
• 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): 12/11/2017

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: 02/07/2021
• Device Model Number: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0212755672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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