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 Cardiac Arrest (1762); 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

Baraka, an: tension pneumothorax complicating jet ventilation via a cook airway exchange catheter.Anesthesiology 1999: (91) 557-8.The above referenced article reports that a patient was undergoing a planned laparoscopic cholecystectomy.The trachea was intubated using a 6 id oral endotracheal cuffed tube; glottis view was limited during intubation.The tube was changed to a larger size using a cook airway exchange catheter due to the patients' body weight.The exchange catheter, with an internal diameter of 3 mm, was inserted into the tracheal tube and advanced until resistance was felt.This was interpreted as the carina.A high-pressure (50 pounds per square inch) oxygen source with a hand controlled interrupter valve was connected to the proximal end of the exchange catheter via a luer-lock adapter.Jet ventilation was started resulting in visible inflation of the right chest but incomplete deflation.Cardiac asystole (isoelectric electrocardiograph) was noted after only three jet pulses.The development of tension pneumothorax was considered.The exchange catheter was withdrawn, and ventflation via the endotracheal tube and cardiopulmonary resuscitation were initiated.Chest auscultation revealed decreased air entry to the right lung.Needle thoracoscopy resulted in an audible escape of air and was followed by restoration of sinus rhythm.Cardiac arrest lasted 150 s.A right chest tube was inserted.Anesthesia and controlled ventilation were maintained via the original endotracheal tube throughout surgery because of this complication.The patient recovered without complication.

Manufacturer Narrative

Investigation - evaluation a review of documentation, drawing, instructions for use, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.The instructions for use (ifu) for the device explicitly states to ensure that the tip of the cook airway exchange catheter is always above the carina, preferable 2-3 cm, to avoid barotrauma.Further, the paper indicated that a high-pressure (50 pounds per square inch) oxygen source was connected to the proximal end of the exchange 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 pressure was started lower and slowly increased to 50 pounds per square inch versus starting straight from that high pressure.Finally, paper states the jet ventilation applied resulted in "visible inflation of the right chest but incomplete deflation".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 clearly was not the case in this situation.A high flow of oxygen or oxygen jet ventilation delivered via the lumen of the catheter or the bronchoscope may result in barotrauma and catastrophic tension pneumothorax.There is no evidence that the device was manufactured out of specification or that the failure was product related.A device history record review could not be performed as the complaint lot number was not provided.Based on the provided information, no product returned, and the investigation, the most likely root cause is related to product use or handling.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6661235
• MDR Text Key: 78186616
• Report Number: 1820334-2017-01473
• 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: 06/22/2017
• 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-14.0-83
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 90