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| Model Number N/A |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cardiac Arrest (1762); Hypoxia (1918); Pneumothorax (2012); Brain Injury (2219); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/06/2022 |
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Event Type
Death
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Event Description
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It was reported that an adverse event occurred with a cook airway exchange catheter.The device was required to facilitate airway exchange in a complex polytrauma patient undergoing complex spinal surgery.At the end of the surgery, the airway exchanged catheter (aec) was used to aid in endotracheal tube (ett) exchange.During the ett exchange, the patient experienced oxygen desaturation; therefore, jet ventilation was performed with the aec and the rapifit connector.Subsequently, the patient experienced "massive" subcutaneous emphysema and precipitated cardiac arrest.As result of this event and the additional time needed to establish a secure airway, the patient experienced hypoxic brain damage and died "several days later".
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Manufacturer Narrative
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Report source - other: competent authority, mhra ref: (b)(4).Pma/510(k) #: exempt.Annex e: code e2402 was selected to capture subcutaneous emphysema.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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional event information was provided on 30mar2023.At approximately 16:03h on (b)(6) 2022, the patient was walking on an embankment near the (b)(6).A car honked at him and the patient lost his balance and fell 20-40 feet into parking lot, landing head first.It was noted that the patient had recently started taking pregabalin, which had affected his balance.The fall was witnessed by the public.The patient was unresponsive at the scene.Lifeguards responded and started basic life support.They were assisted by physicians who were bystanders at the scene.An oropharyngeal (op) airway was inserted, bag-valve-mask ventilation commenced, and an automated-external defibrillator (aed) was applied.The aed did not advise any shocks should be given.An ambulance was called at 16:04h and arrived at the scene at 16:21h.Upon the paramedics arrival, cardiopulmonary resuscitation (cpr) was ongoing.On initial assessment, the patient was noted to have a carotid pulse and was making respiratory efforts.The op airway was replaced with a supraglottic airway.The paramedics and patient left the scene at 16:48 for (b)(6) hospital(b)(6).During transport, the patient¿s conscious level improved, with purposeful eye movements and head movement (no other limb movement) and increasing agitation related to the supraglottic airway (began to chew on the device).The ambulance arrived at (b)(6) emergency department (ed) at 17:05.Ethanol levels were assessed per trauma series protocol.After completion of the primary and secondary surveys, the supraglottic airway was removed and the patient¿s glasgow coma scale (gcs) improved to 15/15.A computed tomography (ct) trauma series was performed which showed the following: ¿ frontal skull fracture with pneumocephalus ¿ intracranial subdural and subarachnoid hemorrhage ¿ fractures of 1st to 8th right side ribs and 1st to 8th left side ribs with a flail segment from 2nd to 5th ribs ¿ small left side pneumothorax and hemothorax with bilateral contusional lung injuries ¿ fracture of c1 and spinous processes of c6 and c7 ¿ fracture of spinous processes of t1, t2, t3, t6, and t7 ¿ fracture of transverse processes of t1, t6, t7, t8, t9 bilaterally, and t2 on the left only ¿ fracture of vertebral bodies of t3, t6, t7, and t8 ¿ possible pedicle fracture of t9 ¿ cervical and thoracic spinal fractures with retropulsion of bony fragments in the thoracic spine at the level of t6 and t7 ¿ fracture of the right clavicle and of the sternum.As a result of these injuries, the patient¿s tetraplegia (unable to voluntarily move the upper and lower parts of the body) and spinal shock, the patient was discussed with the on-call neurosurgical team at (b)(6) hospital in plymouth and was accepted for transfer for surgical stabilization of the thoracic fractures.No trauma transfer team was available overnight.On (b)(6) 2022, the patient was transferred to the ed at (b)(6) hospital, arriving at approximately 15:00.Upon arrival, the patient was spontaneously ventilating, receiving supplementary oxygen via nasal cannula, his blood pressure was supported via metaraminol infusion and pain relief was provided via fentanyl patient-controlled analgesia (pca) with ketamine boluses (the patient was unable to manage the pca himself due to his spinal injury).A new finding of priapism was noted upon arrival, and the patient was subsequently transferred to the neuro-intensive care unit (icu) via the magnetic resonance imaging (mri) scanner.The patient was admitted to the icu at approximately 18:45h.Critical care management was continued and respiratory support in the form of non-invasive ventilation (niv) was to be provided as required to aid carbo dioxide (co2) clearance.When the patient first arrived on icu, the level of co2 present was acceptable hence niv was not commenced.The neurosurgical team saw the patient at 19:01 and outlined the surgical treatment plan with the patient, which primarily involved surgical stabilization of the thoracic fractures.It was noted that ¿there is no urgency to perform surgery, and that surgery can be done on the first elective list on monday¿, and arrangements were made to convey the necessary information to the surgeon on duty for that day.On (b)(6) 2022 at 00:24h, niv was commenced to aid with rising co2.The patient complained of pain, despite ketamine and fentanyl infusions and the decision was taken to site bilateral serratus anterior blocks and local anesthesia infusion catheters (these were placed by the on-call anesthetic registrar at 00:59).At around 01:45h, the patient was found unresponsive with falling oxygen saturations (spo2), which over the course of 7.5 minutes, dropped to a nadir of approximately 50% with a concurrent drop in blood pressure.The patient was treated with vasopressor boluses and a facemask ventilation with an op airway.The icu registrar discussed the patient with the on-call critical care consultant and it was agreed to proceed to intubation.Prior to intubation, the patient was eye opening spontaneously (gsc was otherwise difficult to determine).The icu intubation check list was performed and after adequate pre-oxygenation, intubation was attempted using a video laryngoscope by the icu registrar.Two initial attempts using a standard mac 4 blade were unsuccessful.A further attempt was made using a hyper-angulated d-blade.A hyper-angulated stylet was not used.A supraglottic airway was inserted but the team was unable to ventilate.Facemask ventilation was resumed between all attempted airway interventions.The anesthetic registrar arrived after a call for help was placed.After discussion, it was agreed that a further attempt at intubation would be attempted, with a plan to proceed to asleep fiberoptic intubation if unsuccessful.The video laryngoscope d blade was used, the epiglottis was identified and a bougie successfully passed into the trachea.Attempts to pass size 9.0 and 8.0 endotracheal tubes (ett) were unsuccessful; however, a size 7.0 cuffed oral ett was successfully placed.Capnography was confirmed.The patient was sedated and required minimal support with oxygenation, with fio2 being weaned to 30% with corresponding spo2 of greater than 95%.Sedation was lightened later that morning (sunday).The patient was schedule for a ¿2 level posterior instrumental thoracic fusion¿ on monday (b)(6) 2022.The neurosurgical team reviewed and confirmed the case.The patient was reviewed by the anesthetist assigned to the patient¿s operating room (or).The anesthetist was expecting two elective cases and was not expecting the emergent add on.The anesthetist attended the patient at 09:00h and received report from the nurse which included a summary of the difficult intubation and a request to upsize the ett.The anesthetist was concerned about prone procedure related to the patient¿s thoracic injuries and pneumothorax and sought advice from a thoracic surgeon.It was determined that a chest drain was not required currently, and the patient should remain intubated and ventilated.Surgical chest stabilization was also not required.The anesthetist completed the anesthetic chart and noted the emergency intubation was very difficult.The anesthetist then returned to the or and spoke with the surgical team and discussed plan.The patient was to be prone for 5-6 hours.The anesthetist preferred an armored ett for prone surgery.The need for airway exchange was questioned within the anesthesia team [the anesthesia team consisted of a consultant anesthetist, registrar, and operating department practitioner (odp)] but the senior clinician involved felt that there was a real possibility that the icu ett could become obstructed peri-operatively and believe the armored tube was the safest option.The patient was transferred from the icu to the or at about 10:21h.The patient¿s airway was assessed with the patient on the icu bed.The airway was deemed a grade 1.The plan was to exchange the ett on the icu bed.Anesthesia was deepened and the patient was paralyzed, confirmed by depth of anesthesia monitoring (bis) and qualitative neuromuscular function monitoring (tof ratio).The patient was preoxygenated.A video laryngoscope and with a hyperangulated d blade was inserted.The ett cuff was deflated and air leak confirmed.The cook airway exchange catheter (aec) was inserted down to a depth corresponding to 35cm at the tracheal connector of the ett.Manual jet ventilation was performed using a competitor's high-pressure source ventilation device with confirmation of chest rise and fall.The size 7.0 armored tube was railroaded over the aec.The aec was removed and the armored tube cuff was inflated.Ventilation was confirmed.The armored ett was secured at 23cm at the level of the teeth.It should be noted that the consultant anesthetist operated the jet ventilation device while the registrar exchanged the etts.It is unclear was pressure was used for the jet ventilation device.Following jet ventilation a chest x-ray was performed at 11:25h to exclude a pneumothorax.No pneumothorax was observed and the case continued.The patient was then positioned prone with his head supported in pins and the t5-6 and t8-9 posterior instrumental thoracic fusion and decompression surgery began.The surgery and anesthesia management during the case were relatively uneventful.It was noted that during the surgery airway pressures and oxygen requirement increased.The patient also received a blood transfusion during the procedure.The surgery was completed at about 17:00h and the patient was reversed to the supine position.The surgical team left the or at about 17:46.The armored ett was then to be exchanged for an icu ett.The patient¿s face and eyes were noted to be swollen.Adequate anesthesia and paralysis were confirmed.Airway secretions were suctioned.A video laryngoscope with a d blade confirmed a grade 2 view.At 17:55 the evening otp arrived to relieve the day odp.The consultant anesthetist asked both odps to remain for the airway exchange.Both agreed and another consultant anesthetist arrived at this time so the evening consultant anesthetist left and stated they would return later.The same process for exchange performed at the beginning of the procedure was employed for ett exchange.Anesthesia was deepened and the patient was paralyzed confirmed by depth of anesthesia monitoring (bis) and qualitative neuromuscular function monitoring (tof ratio).The patient was preoxygenated.The consultant anesthetist was to use the jet ventilation device while the registrar exchanged the etts.A video laryngoscope and with a hyperangulated d blade was inserted.The ett cuff was deflated and air leak confirmed.The cook aec was inserted to approximately 30cm at the end o the ett.Two jets via the jet ventilation device were performed with rise and fall of chest.The armored ett was removed.A size 8.0 ett was railroaded over the aec.The first and second attempts into the trachea failed.The third attempt with a twisting motion also failed.At this point the view on the video laryngoscope was lost and the patient began to desaturate.The consultant anesthetist proceeded to jet ventilate the patient, the first jet was uneventful, the second resulted in massive neck, abdominal, and scrotal swelling.This was associated with falling blood pressure and changes to the qrs complex on the ecg.The consultant anesthetist informed the team of an airway emergency and requested emergent front of the neck access (efona) equipment and to commence a cardiac arrest call.The evening consultant anesthetist returned at 18:05 and cpr for pea (pulseless electrical activity) cardiac arrest commenced.Multiple operating room personnel arrived in response to the cardiac arrest call including: ¿ 3 operating department practitioners ¿ 4 consultant anesthetists ¿ 1 icu registrar ¿ 1 consultant intensivist ¿ 1 ent registrar ¿ 2 consultant ent surgeons efona (cricothyroidotomy) was performed by the lead consultant anesthetist.The first attempt was performed with a horizontal incision.A 6.0 ett was inserted and connected to the breathing circuit.High-pressure on the bag was noted, and no etco2 was visible on the monitor.It was assumed the ett was not in the trachea and was therefore removed.A second attempt with a vertical incision was made.Again a 6.0 ett was inserted and connected to the breathing circuit with high-pressure on the bag and no etco2 was visible on the monitor.This occurred between 18:07 ¿ 18:21h.At this time, other attempts at ventilation were made by trying to pass a smaller ett over the aec, insertion of a supra-glottic airway device, or to provide bag-valve mask ventilation.After confirming the ett was in the trachea, it was suggested that the patient may have tension pneumothoraxes and should undergo bilateral decompression.This was performed by the icu registrar.Audible gas was released from the patient and visible etco2 was seen on the monitor.Return of spontaneous circulation occurred between 18:30 and 18:35.Downtime was approximately 20-25 minutes in total.The patient received further resuscitation with medication and three units of packed red blood cells.The consultant anesthetist called the family and informed them that the patient ¿may have suffered a hypoxic brain injury¿.The ent team converted the cricothyroidotomy into a formal surgical tracheostomy and exchanged the size 6.0 cuffed ett for a 8.0 tracheostomy tube with subglottic suction port.The patient was taken to radiology for a ct prior to returning to the icu.The findings are as follows: ¿ subdural/subarachnoid bleeding.No new findings ¿ abdomen with retroperitoneal extension likely from viscus perforation; potentially lesser sac of stomach or esophagus at the level of the thoracic inlet ¿ tiny residual pneumothoraxes.Bilateral chest drains in situ.¿ the ct was discussed with a gi radiology consultant who stated ¿no esophageal/gi perforation and surgical emphysema/pneumoperitoneum is all arising from his fractured ribs worsened by chest compressions and airway pressure the ct was later reviewed by the trauma team on (b)(6) 2022 and amended as: 1.In the absence of visceral injury, the appearances of diffuse gas maybe in keeping with high pressure ventilation.There is a small speck of intramural gas within the upper esophagus and esophageal perforation is not excluded.2.Both chest tubes are inadequately positioned with the proximal drainage holes within the subcutaneous tissues ¿ this is likely to have contributed to the extent of the subcutaneous emphysema.The patient was then transferred back to the neuro icu after the ct.The following day (b)(6) 2022, the patient displayed rhythmic eyelid movements and facial twitching on sedation hold.Seizure active was questioned.On (b)(6) 2022, ongoing facial twitching and seizure activity was observed.An egg was performed at 10:15h and the report stated: ¿pattern is consistent with ictal state and given the persistence compatible with status epilepticus (myoclonic), which in the current clinical setting occurs on the background of severe hypoxic brain injury.¿ on (b)(6) 2023, the patient continued to display ongoing facial twitching; however, no seizure activity was note whilst eeg is on.Patient monitoring continued from (b)(6)2022.On (b)(6) 2022, the family was briefed by the consultant intensivist and ultimately elected for comfort care.Patient death occurred on (b)(6) 2022 at 17:10h.Post-mortem examination was performed on (b)(6) 2022.The summarized findings are as follows: cause of death:- 1a- bilateral bronchopneumonia due to hypoxic brain injury 1b - airway obstruction during intubation 1c- multiple injuries die to fall from a height a notable finding was that the larynx was still acutely swollen with a finger unable to pass.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a investigation ¿ evaluation a physician from the difficult airway society (das) in the united kingdom contacted cook on (b)(6) 2023 concerning a c-cae-14.0-83 set from an unknown lot.The event occurred on (b)(6) 2022 at derriford hospital.The exchange catheter was used to facilitate airway exchange in a complex polytrauma patient undergoing spinal surgery.The exchange catheter was used in conjunction with a manujet iii ventilator by use of the rapifit connector sent with this cae set.The patient deteriorated during the exchange, the jet ventilator was used, and the patient suffered massive subcutaneous emphysema, which precipitated a cardiac arrest.Due to this, and the time needed to establish a good airway, the patient was without oxygen for an extended period, leading to brain damage.The patient passed away several days later.Reviews of the documentation, including the complaint history, device history record, 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, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure non-conforming material does not leave house.The customer did not provide a lot number.A sales report for the customer was performed and seven possible lots shipped to derriford hospital from (b)(6) 2019 through (b)(6) 2022 were identified.A review of the device history record (dhr) for these seven lot numbers found no nonconformances that could have contributed to the reported failure mode.It should be noted that no other complaints were associated with these lot numbers.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_cae_rev6.In the instructions for use section under use of rapi-fit adapter it states: note: use of a high-pressure oxygen source should only be considered if the patient has a sufficient egression of the insufflated gas volume.Under the endotracheal tube exchange section, it states: note: it is recommended that a sterile lubricant be applied to the orifice of the endotracheal tube prior to introduction of cae catheter.Note: if a high-pressure oxygen source is used for insufflation (e.G., jet ventilator), begin at lower pressure and work up gradually.Rising chest wall, pulse oximetry and oral air flow should be carefully monitored.The intended use section states: the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchanges.Evidence gathered from a review of the dmr, dhr, cook determined the device was manufactured to specification.There is no evidence of nonconforming product in house or in the field.Based on the information provided, no returned product, and the results of our investigation, it was concluded that the cause of the failure could be associated with an unintended user error.The device was used in a patient with a difficult airway, the catheter was over-inserted, and jet ventilation may not have been used in a manner consistent with the ifu.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.
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