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

Model Number N/A

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012); Pulmonary Dysfunction (2019)

Event Type  Injury  

Event Description

In the literature article by authors mcdonald and liban, "a serious complication with an airway exchange catheter" published in clinical intensive care (1997), it was reported that a 69-year-old male patient experienced a pneumothorax following the use of a cook airway exchange catheter during a tracheal tube exchange.The patient was admitted to the icu following a re-do coronary artery bypass graft surgery.On the 10th post-operative day he had an asystolic arrest; it was thought that the cardiac arrest could possibly have been caused by a pulmonary embolus.By post-operative day 18 the patient had developed a partially blocked ett with associated leak and ventilatory compromise and required an endotracheal tube (ett) exchange.Reintubation was anticipated to be difficult, so it was decided to use a cook airway exchange catheter to facilitate tube exchange.The cook catheter was prepared for jet ventilation with 100% oxygen at 50 psi.The lubricated catheter was passed down the ett and the ett cuff was deflated.The patient was ventilated with a 1-second inspiratory time at 15 breaths/min with good chest movement and air entry.The old ett was removed and attempts were made to advance a new lubricated ett; however this was unsuccessful as the new ett could not be advanced past the vocal cords.Therefore, while continuing to jet ventilate, direct laryngoscopy was performed and the new ett eventually passed with difficulty.At the time of laryngoscopy, subcutaneous emphysema was observed and the patient began to experience cardiopulmonary compromise.A pneumothorax was detected and treated with bilateral thoracic drainage.There was no improvement seen in the patient following drainage placement.Cardio pulmonary resuscitation (cpr) was administered for five minutes before resuscitation attempts were ceased.The patient then passed away.An autopsy was conducted and revealed evidence of a pulmonary embolism and a dilated heart, with only two out of six coronary artery bypass grafts remaining patent.The patient's airways were found to be normal.Article discussion indicated that it was presumed the patient¿s acute deterioration was due to pneumothorax.The authors postulate that using excessive source pressure with some degree of upper airway obstruction and possible distal movement of the catheter (into the right main bronchus), the necrotic infarct (from the pulmonary embolus) gave way leading to pneumothorax.Literature citation: mcdonald, d.S.And liban, j.B.(1997).A serious complication with an airway exchange catheter.Clinical intensive care, 8, 36-37.Doi: https://doi.Org/10.3109/tcic.8.1.36.37.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Date of event: occurred in or prior to 1997.Initial reporter - customer (person): postal code: (b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: cook became aware on 14sep2022 of the literature article by authors d s mcdonald & j b liban (1997), "a serious complication with an airway exchange catheter", published in clinical intensive care, 8:1, 36-37, doi: 10.3109/tcic.8.1.36.37 (b)(6) hospital had difficulty using a cook airway exchange catheter (rpn: c-cae-19.0-83; lot: unknown) during a tracheal tube exchange in a 69 year old male patient.The customer stated that the catheter was matched to the length of the tracheal tube and prepared for jet ventilation with 100% oxygen at 50 psi.The lubricated catheter was passed down the tube and the cuff deflated.The tube was removed, and a new lubricated tube was advanced over the catheter and attempts to advance through the cords were made.Unfortunately, this was not possible.While continuing to jet ventilate, direct laryngoscopy was performed to aid introduction of the new tracheal tube which eventually passed with difficulty.The catheter was removed, and bag ventilation was performed.At the time of laryngoscopy, they noticed sudden right-sided subcutaneous emphysema associated with cardiorespiratory collapse.A pneumothorax was diagnosed, and a right-sided chest drain immediately inserted with a resultant rush of air.A left-sided chest drain was also inserted without any improvement.After five minutes, resuscitation was abandoned, and the patient passed.The customer states that they feel the patient¿s deterioration was due to pneumothorax, but unsure what factors led to it.The customer is unsure if the cook catheter is at fault.The customer states: we postulate that using excessive source pressure with some degree of upper airway obstruction and possible distal movement of the catheter (into the right main bronchus), the necrotic infarct (from the pulmonary embolus) gave way leading to pneumothorax.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The customer did not provide a lot number; therefore, a sales report was performed.The customer has received five possible lot numbers.A review of the dhrs for the possible lot numbers revealed no non-conformances.Based on the available information, cook was not able to find evidence the device was manufactured out of specification.There is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_cae_rev6.In the device description section, it states: for use in replacement of endotracheal tubes whose inner diameter (id) is 7 mm or larger.In the instructions for use section, it states: note: use of a high-pressure source should only be considered if the patient has sufficient egression of the insufflated gas volume.1.) before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be placed, confirm correct endotracheal tube position.2.) using the outer margin of the patient¿s mouth or nasal orifice as a landmark, note the marking on the endotracheal tube.A piece of tape or other marker may be placed on the cae catheter at the corresponding distance from the tip to aid in correct placement within the endotracheal tube.3.) advance the cae catheter, side ported end first, into the endotracheal tube to be replaced.Note: it is recommended that a sterile lubricant be applied to the orifice of the endotracheal tube prior to introduction of cae catheter.Caution: to avoid barotrauma, ensure that the tip of the cae catheter is always above the carina.Preferably 2-3 cm.Note: if a high-pressure oxygen source is used for insufflation (e.G., jet ventilator), begin at a lower pressure and work up gradually.Rising chest wall, pulse oximetry and oral air flow should be carefully monitored.4.) properly position the cae catheter within the endotracheal tube by aligning the appropriate centimeter mark on the cae catheter with the corresponding centimeter mark on the endotracheal tube.This placement is determined by visualizing the indicated centimeter length of the endotracheal tube, in place, as shown on its surface scale.5.) fully deflate the cuff of the endotracheal tube and remove the rapi-fit adapter, while maintaining the position of the cae catheter.Remove the endotracheal tube, leaving the cae catheter in place.6.) maintaining position of the cae catheter, using the patient¿s mouth or nasal orifice (depending on approach) as a landmark, advance the new endotracheal tube over the cae catheter and position appropriately.Note: it is recommended that a sterile lubricant be applied to the tip of the endotracheal tube prior to advancing the tube.7.) remove the cae catheter and inflate the balloon cuff of the new endotracheal tube.Re-establish ventilatory device use and secure the new endotracheal tube in place.Confirm its position using standard methods.In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no device return, and the results of the investigation, the cause for this event could not be established.There is no evidence of component failure.The customer stated that they are unsure if the cook catheter is at fault.The customer had difficulty trying to advance the new tube through the patient¿s vocal cords.The customer postulated that it is possible that the attempts to advance the new tube could have caused trauma leading to the pneumothorax.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15461474
• MDR Text Key: 300307102
• Report Number: 1820334-2022-01511
• 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: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 96 KG