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

Model Number	8229708
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the tube found that under magnification there was a 0.025¿ puncture in the cuff on the exterior of the radius (midline) and on the proximal side of the cuff.A syringe was used to inflate the cuff with 10cc of air and it leaked out immediately.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the device had a pin hole in the balloon during a right thyroid lobectomy procedure.The defect was detected when the patient was intubated, so the tube was removed and the patient was re-intubated with a new tube.The patient suffered no injuries and the procedure was only briefly delayed.The patient was reintubated to prevent serious injury or death.The hcp also noted that it was the first time the tube was used.

• 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: 7886732
• Report Number: 1045254-2018-00437
• Device Sequence Number: 2725881
• Product Code: ETN
• UDI-Device Identifier: 00643169060807
• UDI-Public: 00643169060807
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 01/11/2020
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0210655939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: 49 YR
• Patient Weight: 160