MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Shaikh, n, et al: endotracheal tube exchange and pneumothorax: a case report.Case reports in clinical medicine, 2 (2013) 183-185.The above referenced journal article alleged that a patient with multiple co-morbidities underwent a total thyroidectomy.Intubation was reported as difficult following the procedure.The patient was admitted to the icu for visualization of vocal cords and the resecuring of the airway.Video-laryngoscopy on post-operative day (pod) 2 showed immobile left vocal cord, supra glotic airway collapse and arytenoids cartilage edema.A repeat video-laryngoscopy on pod 5 showed supraglottic edema with difficulty to assess vocal cord movement.The patient was extubated using a cook aintree intubation catheter (aec) to reassess the vocal cord movement and resecure the airway if needed.The catheter was inserted and patient supplemented with 6 liters per minute of oxygen.Oxygen saturation (spo2) dropped to 70%, and the patient developed bradycardia along with hypotension.The patient was extubated and cardiopulmonary resuscitation initiated with ambu bag ventilation.Within 2 minutes spo2, heart rate and blood pressure improved.A chest x-ray showed a left pneumothorax necessitating placement of a chest drain.A follow-up x-ray showed a well expanded left lung however a localized air-filled cavity was identified suggestive of a lung laceration which disappeared after 24 hours.Bronchoscopy showed no tracheobronchial injury.The patient was weaned off mechanical ventilation on pod 10, follow-up laryngoscopy showed resolution of the supraglottic edema with normal vocal cord movement.The patient was discharged home on pod 22.The authors suggest that the pneumothorax may be the result of the aec migration trapping air during emergent positive pressure ventilation.

Manufacturer Narrative

Investigation - evaluation a review of documentation, complaint history, drawing, manufacturing instructions, instructions for use (ifu), and quality control (qc) data was conducted during the investigation.Complaint sample evaluation was not performed since no product or imaging was returned to assist with this investigation.Additionally, since the lot number was unknown, the device history record and related non-conformances could not be reviewed.The manufacturing documents relating to this device were reviewed and it was determined that there are adequate controls in place ensuring the quality of the airway exchange catheter.Current risk controls include depth marks located on catheter shaft for insertion depth guide, inspection of device functionality and characteristics in final qc prior to shipping, and instructions for use outlining proper procedure of device use and warnings against over-insertion and utilization of a high pressure oxygen source.After review of the event details laid out in the journal article, it is possible that the failure was user-technique related and/or not following proper instructions.This can be attributed to either the catheter being inserted too far into the patient, inappropriate use of a high pressure oxygen source, or too high of a flow/no gradual increase of oxygen delivered via jet ventilator.Any of these could have led to pneumothorax.The paper indicated that a high-flow (6 l/min) oxygen source was connected to the catheter.Per the ifu, if a high-pressure oxygen source is used for insufflation (e.G., jet ventilator), begin at lower pressure and work up gradually.There is no indication that the flow was started lower and slowly increased to 6 l/min versus starting straight from that high flow.The ifu notes that the use of a high-pressure oxygen source should only be considered if the patient has sufficient deflation of the insufflated gas volume which was likely not the case in this situation.The use of jet ventilation with cook airway exchange catheter (aec) can lead to sudden higher airway pressures and no sufficient room for exhalation, causing barotrauma and/or pneumothorax.Finally, per the ifu, the intended use of the catheter is for "uncomplicated, atraumatic endotracheal tube exchange" which was likely not the case since this patient had experienced several complications prior to this placement (upper airway obstruction, immobile vocal cords, supra glottis edema) and it was noted that the previous tracheal intubation was "difficult".However, without visual, dimensional, or functional testing of the involved device we cannot say with certainty if the main cause of failure was technique related, procedure related, human anatomy related or device related.The appropriate personnel will be notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6652021
• MDR Text Key: 77913649
• Report Number: 1820334-2017-01602
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening