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

Model Number	8229708
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; device was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The sales rep reported that the facility has had four events reported with product number 8229708.In each of the events, the cuff would not hold air after the patients were already intubated.The patients had to be reintubated in each case.The four incidents have been with the same doctor and same size tube.A regulatory report will be filed for event 1 of 4 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).Another regulatory report will be filed for event 2 of 4 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).Event 3 of 4 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)) is being investigated; however, a regulatory report will not be submitted.This regulatory report is being filed for event 4 of 4 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).A total thyroidectomy was being performed during this event.The emg tube was checked for the patency prior to intubating.The airway was established, then within 30 minutes an air leak was discovered by a sound.At this point the patient was reintubated with another tube.The procedure was completed and there was no impact to the patient.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 8229708 from lot number 0213841181.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.A syringe was used to inflate the cuff with 20cc of air and it leaked out immediately.Under magnification it was determined there was puncture and abrasions in the cuff.The puncture was concave and measured 0.6¿ long.The device condition was out of specification as it relates to the complaint.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 n; jacksonville FL 32216
• MDR Report Key: 6963453
• Report Number: 1045254-2017-00373
• Device Sequence Number: 16531412
• Product Code: ETN
• UDI-Device Identifier: 00643169782600
• UDI-Public: 00643169782600
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 08/14/2021
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0213841181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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
• Patient Age: 70 YR