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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problems Internal Organ Perforation (1987); Paralysis (1997); Brain Injury (2219); Coma (2417); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2009

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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

In this literature article "coma and seizures due to gas emboli following extubation" a complication related to an unknown cook airway exchange catheter was reported.The authors report the following: "case report: we present a 29-year-old man with cerebral arterial gas embolism (cage) due to barotrauma sustained during extubation.The patient, who had a history of bipolar disorder and smoking, had been admitted for an open pyeloplasty, performed for ureteric obstruction.This was complicated by post-operative haemorrhage requiring further surgery and intensive care admission.Three days later he was alert and following commands.Intubation had been difficult (grade 2¿3 cormack¿lehane laryngoscopic assessment); therefore, a cook airway exchange catheter, which allows oxygen to be administered during potentially difficult extubation or re-intubation (fig.1), was used as a precaution.It was passed 35 cm beyond the endotracheal tube (ett).During extubation the patient became pale and diaphoretic, his teeth clenched around the cook catheter and airway protection was compromised.Oxygen (8¿10 l/min) and propofol were administered and rapid re-intubation was achieved by ¿rail-roading¿ the ett over the cook catheter.There was bradycardia and hypotension for about 15 s and the event lasted 2.5 min in total.Cardiopulmonary resuscitation was briefly performed although oxygen saturation remained >95%.Post-intubation chest x-ray revealed subcutaneous and mediastinal emphysema and bilateral pneumothoraces were subsequently identified on a chest ct scan.Several hours after the event, despite no further sedation and empirical administration of flumazenil and naloxone, the patient remained comatose.On examination, the patient was afebrile but tachycardic.Subcutaneous emphysema was palpable.There were conjugate roving eye movements, although fundoscopic and pupillary examinations were normal.Corneal and vestibulo-ocular responses were present.There were no involuntary movements, no response to voice, and bilateral flexion responses to pain.Deep tendon reflexes were increased in the left upper limb.He had been empirically loaded with phenytoin but 12 hours after the event secondary generalised seizures developed with onset in the left hand.Seizures recurred over 24¿36 hours and a video-electroencephalogram (eeg) confirmed a right frontal electroencephalographic onset.Initial cerebral ct scan excluded acute infarction, haemorrhage or intravascular air but diffuse cerebral oedema was evident on a repeat ct scan at 24 hours.Despite control of seizures the patient remained comatose for several days.Over the next three weeks he improved, became interactive and was successfully extubated.Five weeks after the event he was discharged with a subtle left hemiparesis, disinhibition, emotional lability and moderate memory impairment.Residual cognitive deficits were detailed by neuropsychological assessment after discharge.Convalescent mri demonstrated cerebral atrophy and thinning of the corpus callosum, consistent with a diffuse hypoxic insult.Multiple small right frontal and periventricular hyperintensities on t2-weighted mri sequences were appreciated.The diagnosis of cage was established after clinical, radiological and eeg demonstration of acute diffuse and focal cerebral injury in the immediate context of barotrauma.In this case, barotrauma was caused by advancement of the cook catheter.The tip of the catheter (noted to be blood stained) damaged lung parenchyma and pulmonary vessels, which allowed direct entry of bubbles of inhaled gases into the pulmonary veins, left heart and ultimately the systemic arterial system.High flow oxygen insufflation (8¿10 l/min) would have exacerbated entry of gas into the pulmonary veins.The reverse trendelenburg position promoted rostral flow of gas emboli to the brain.Emboli of variable size occluded both large and small cerebral vessels (usually 30¿60 ¿m average diameter)[2] resulting in focal and diffuse cerebral injury respectively.Arterial hypoxaemia and systemic hypotension were discounted as causes because oxygen saturation and blood pressure were continuously monitored before and during the episode.A right frontal infarct, demonstrated clinically and radiologically, would be unusual for a hypoxic ischaemic insult, but cage typically results in the combination of focal and diffuse injury.[2] metabolic and pharmacological causes of coma were excluded through investigations and withdrawal of sedative medications.Seizures were controlled within 72 hours of attempted extubation.Hemiparesis,[9] depressed consciousness, seizures[3] and cognitive deficits, all evident in this case, are well described in cage.Transcranial doppler ultrasonography or cerebral ct scans may occasionally demonstrate intravascular gas,[6] although gas emboli are often too small to be visualized with conventional imaging techniques.Treatment of cage is primarily supportive.In this case, hyperbaric oxygen was contraindicated by barotrauma,[11] but the emboli would have had a high fraction of oxygen as a result of pre-oxygenation and cook catheter insufflation.This would have increased oxygen diffusion and reduction in bubble size, probably contributing to a more favourable outcome." this report focuses on the following event reported in the article: barotrauma was caused by advancement of the cook airway exchange catheter.The tip of the catheter (noted to be blood stained) damaged lung parenchyma and pulmonary vessels, which allowed direct entry of bubbles of inhaled gases into the pulmonary veins, left heart and ultimately the systemic arterial system.No other adverse effects were reported for this incident.Citation: burrell, j.R., hayes, m., thanakrishnan, g., & peters, m.(2009).Coma and seizures due to gas emboli following extubation.Journal of clinical neuroscience, 16(2), 344¿345.Https://doi.Org/10.1016/j.Jocn.2007.11.013.Doi link: https://doi.Org/10.1016/j.Jocn.2007.11.013.

Manufacturer Narrative

Investigation ¿ evaluation: on 13oct2022, cook became aware of literature originating (b)(6) hospital nsw (australia) concerning an unknown c-cae device from an unknown lot.The patient was intubated for surgery.Surgical complications occurred, in which the patient remained intubated and was moved to intensive care.Three days later, the patient¿s condition improved, so the provider decided to remove the breathing tube.It was noted that the tube was hard to place during intubation, so the provider decided to extubate the patient using a cook cae device.As stated in the article, the user advanced the cae 35cm beyond the breathing tube that was in the patient.The cae caused damage to the lung, which resulted in the barotrauma that led to the required cpr, gas embolism, seizure, coma, etc.Reviews of the documentation, including the instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be completed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified that prevent nonconforming material from leaving house.A review of the device history record (dhr) for could not be conducted due to the lack of lot information provided in the article.Based on the dmr and the information contained within the article, there is no evidence to suggest the device was manufactured out of specification or that there is nonconforming product in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_cae_rev6.In the warnings section it states: attention should be paid to insertion depth of catheter into patient¿s airway and correct tracheal position of replacement endotracheal tube.Markers on the cook airway exchange catheter refer to distance from tip of catheter.Catheter and endotracheal tube should not be advanced beyond the carina.To avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3 cm.In the instructions for use section, it states: 2.) using the 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.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.6.) maintaining position of the cae catheter, using patient¿s mouth or nasal orifice (depending on approach) as a landmark, advance the new endotracheal tube over the cae catheter and position appropriately.Based on the information provided, no returned product and the results of our investigation, it was concluded that an unintentional user error contributed to the reported event.The customer stated that the catheter was extended beyond the intended location.These devices have markers to indicate where the device is in the patient.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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.

Event Description

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

• 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: 15655291
• MDR Text Key: 302246947
• Report Number: 1820334-2022-01651
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOTRACHEAL TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization; Disability
• Patient Age: 29 YR
• Patient Sex: Male