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

Model Number	8229308
Medical Device Problem Codes	Partial Blockage (1065); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Airway Obstruction (1699); Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical safety has assessed the event and stated that this is a use error issue and the event and it¿s severity are known and labeled per ifu m726750c793 a, which states: inflation of the cuff by ¿feel¿ alone, or by using a measured amount of air is not recommended since resistance is an unreliable guide during inflation.Intracuff pressure should be closely monitored with a pressure measuring device.Do not overinflate the cuff.Ordinarily, the cuff pressure should not exceed 25 cm h2o.Carroll and greenvik recommend maintaining a seal pressure at or below 25 cm h2o (carroll, r.G., and greenvik, a.: ¿proper use of large diameter, large residual cuffs.¿ critical care medicine vol.1, no.3: 153-154, 1973).Over inflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.Minimal occluding volume or minimum leak techniques should be used in conjunction with an intracuff pressure measuring device in selecting the sealing pressure.Cuff pressure should continue to be monitored thereafter, and any deviation from the selected seal pressure should be investigated and corrected immediately.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the external bulb of endotracheal tube that would normally indicate cuff inflation failed and this caused more air to be placed into the cuff.The cuff was so compliant that it overinflated and obstructed the ett causing a failed ventilation situation.The patient desaturated and we were not able to ventilate.They ended up having to remove the nims tube and replacing it with a traditional ett.The patient did well at that point.The problem they encountered was twofold.First the cuff on the nims tube is too compliant and can easily be overinflated and herniate forward to occlude the tube openings.Second, the pilot bulb is too stiff and does not inflate appropriately to indicate cuff inflation.This is a serious patient care issue that could have resulted in patient harm or death.On follow-up, it was reported that the issue was not evident prior to intubation; the cuff was briefly inflated with 10ml air to confirm cuff inflation.The event occurred during a c5-c6 arthroplasty.There was a surgical delay for about 30 minutes as they had to trouble shoot failed ventilation through the nims tube.The patient suffered no long term consequences that they were aware of but there could have been severe consequences as the patient's o2 saturation fell to the 30¿s at one point.They eventually had to remove the nims tube and place a standard ett.Nims tube was found to be functionally defective as the cuff was too compliant and cuff bulb too non-compliant.Cuff bulb did not inflate to indicate cuff inflation and cuff was inadvertently overinflated causing the cuff to herniated forward in the trachea occluding the tube openings.The device has been discarded.Patient history - bmi 42 h/o, anxiety, gout, hypertension.
Additional Manufacturer Narrative
Correction: section e2 and e3 updated as initial reporter's occupation is anesthesiologist.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 14438523
• Report Number: 1045254-2022-00252
• Device Sequence Number: 5151873
• Product Code: ETN
• UDI-Device Identifier: 00643169789548
• UDI-Public: 00643169789548
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: 8229308
• Device Catalogue Number: 8229308
• Device Lot Number: 0223601477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 04/17/2023
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male