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

Model Number	8229307
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results not available; the device was not returned for evaluation.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
It was reported that before the surgery, it was found that the wire had punctured the balloon; it was not used on the patient.There was no patient impact.
Additional Manufacturer Narrative
Product evaluation: the nim emg tube was received for analysis.Visually, the electrode wire was bent at the blue band on the main tube.A syringe was used to inject the cuff with air and it was noticeably leaking in under 5 seconds.The cuff was fully deflated and it was determined that all electrode wires were within their respective lumens.The cuff was inflated again and submerged in water; it was determined the leak was in middle of the cuff (approximately 0.34¿ before the proximal end of the wire in the lumen) and aligned with the bent electrode wire.When viewed under magnification, there was a puncture in the cuff measuring approximately 0.01¿.During the analysis, the cuff was cut at one end and pulled back to view the lumen closest to the cuff puncture, it was punctured as well, and the lumen contained an abrasion on the inside diameter near the puncture.A reserve sample emg tube was manipulated and bent and the damage observed in the complaint sample was reproduced on the reserve sample (punctured cuff / lumen and bent electrode wire).The ifu indicates ¿there is a greater risk of damaging the tube under extreme operating conditions, such as excessive bending, prolonged procedures, and repeated manipulation¿.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6429313
• Report Number: 1045254-2017-00092
• Device Sequence Number: 13637274
• Product Code: ETN
• UDI-Device Identifier: 00643169358713
• UDI-Public: 00643169358713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K925640
• 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,Followup
• Report Date (Section B): 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2019
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0209115556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided; 05/09/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/07/2017; 10/02/2017
• Patient Sequence Number: 1