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	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation was not performed; device was not returned for analysis.
Event or Problem Description
The sales rep reported that the facility has had four issues with product # 8229708.In each of the events, the cuff would not hold air after the patients were already intubated.The patients had to be re-intubated in each case.The four incidents have been withthe same doctor and same size tube.This regulatory report is being filed for event 1 of 4 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).The patient was intubated, prepped and draped for a thyroidectomy.Within twenty minutes, the airway was established, the incision had been made and it was discovered that the balloon (cuff) was not holding air.A slight air noise was heard and the patient had to be reintubated.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.A fourth regulatory report will be filed for event 4 of 4 that occurred on (b)(6) 2017.(medtronic internal reference number (b)(4)).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
One opened sample, part number 8229708, from lot number 0213550049 was received for analysis.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 information most likely indicates inadvertent damage during handling / intubation.The device condition was out of specification as it relates to the complaint.The reported complaint was confirmed.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: 6963974
• Report Number: 1045254-2017-00376
• Device Sequence Number: 13738717
• 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,Followup
• Report Date (Section B): 02/06/2018

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: 06/26/2021
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0213550049
• 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: 09/20/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 02/02/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/12/2017; 02/06/2018
• 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: Required Intervention
• Patient Age: 78 YR