MAUDE Adverse Event Report: COOK INC COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pneumothorax (2012); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: hulst, a.H., avis, h.J., hollmann, m.W., & stevens, m.F.(2017).Massive subcutaneous emphysema and bilateral tension pneumothoraces after supplemental oxygen delivery via an airway exchange catheter.A & a case reports, 8(2), 26-28.Doi:10.1213/xaa.0000000000000414.Concomitant medical products: luer lock rapi-fit adapter, ohmeda o2 flowmeter ((ohio medical, (b)(4)), ett (8mm, safety clear tracheal tube; teleflex, (b)(4)), melker emergency cricothyroidotomy catheter (cook medical), flexi-slip stylet (teleflex).Pma/510(k) number: exempt.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.[(b)(4)].

Event Description

As reported in the journal a & a case reports, a (b)(6)-year-old man with klippel-feil syndrome and obstructive sleep apnea syndrome underwent a revision of a craniocervical posterior spondylodesis under general anesthesia.The anesthesiologist induced anesthesia, mask ventilated the patient, and administered neuromuscular relaxation in preparation for intubation.During direct laryngoscopy, he could not see the epiglottis or vocal cords.Nonetheless, on the first attempt, he successfully placed an ett with the aid of an indwelling stylet.He confirmed correct placement by capnography and bilateral breath sounds at auscultation and fixed the ett at 22 cm distal to the upper central incisors.The 5-hour operation, performed with the patient in the prone position, was uneventful.Anesthesia was maintained by the use of sevoflurane, and norepinephrine up to 0.06 g/kg/min was used intraoperatively for hemodynamic support.Postoperatively, the patient was sedated with propofol and ventilated for 3 hours, with the head of the bed placed in an upright position because of severe facial swelling caused by prolonged prone positioning.Before extubation, the larynx was inspected by videolaryngoscopy, and no significant edema of the larynx was visible.A leak-test (confirmation of audible air movement with a deflated ett cuff) was not performed because of its limited predictive value for reintubation.Because of the cormack lehane iv score at intubation, an aec was left in place after extubation to facilitate reintubation, if necessary.An extra firm, soft-tipped cook 11 fr aec was introduced through the ett without resistance, and with the 40-cm mark of the aec visible at least one hand width outside the end of the tube.The ett measured approximately 37 cm, including its connector that was left in place, and the aec thus did not protrude from the tube at the time of placement.Subsequently, while the patient was awake and breathing spontaneously, the ett was removed and the aec was kept in place manually.Immediately after extubation, a visible rise and fall of the chest and audible breathing were noted.Co2 from the aec was not measured at this point.Snoring suggested that the airway partially was obstructed, which could be explained by the patient¿s obstructive sleep apnea syndrome.During a period of approximately 3 minutes, oxygen saturation gradually declined to 87%.To stabilize oxygenation, 4 l/min of supplemental oxygen was administered via the luer lock rapi-fit adaptor mounted at the proximal end of the aec via an o2 flowmeter.Within seconds, the patient developed subcutaneous emphysema of the lip, face, and neck followed by the thorax, abdomen,and scrotum while his oxygen saturation decreased further to 78%.A size 8 ett was introduced over the aec, the aec was removed, and positive pressure ventilation was started.Unfortunately, no chest movement or expired co2 was noted.Because of the speed of deterioration, location of the ett was not confirmed with a fiberoptic bronchoscope, and direct or video laryngoscopy was not considered because of the swelling induced by subcutaneous emphysema.Instead, the ett was removed and a melker emergency cricothyroidotomy catheter was inserted percutaneously through the cricothyroid membrane into the trachea.After cricothyroidotomy, the lungs could be ventilated with high driving pressures (>40 cm h2o) and co2 was detected in the expired air; however, oxygen saturation had continued to fall, and the patient developed asystole.Cpr was started, but chest compressions were nearly impossible because of the stiffness of the chest.Needle thoracentesis was attempted, but the pleurae were not reached because of subcutaneous swelling.Bilateral chest tubes were inserted with audible release of air, and subsequently effective chest compressions were delivered.Return of spontaneous circulation was achieved after 12 minutes, with a 24-minute duration of oxygen saturation below 80%.A chest x-ray,ordered after chest tube insertion, showed extensive mediastinal and subcutaneous emphysema.Surgical tracheotomy was performed with the femoral vessels cannulated and extracorporeal circulation facilities in stand-by.Ventilation pressures had returned to normal, and the patient was admitted to the intensive care unit for postresuscitation support.Unfortunately, the patient had developed a persistent postanoxic coma.Bronchoscopy (via the mouth and through the tracheotomy) and a computed tomography scan did not reveal bronchial or tracheal lacerations.At discharge to a neurological care facility on postoperative day 27, the patient remained ventilated via tracheostomy, had a glasgow coma scale score of 8, could open his eyes spontaneously, withdrew from painful stimuli, and had a tracheostomy tube in situ.

Event Description

On 21oct2019, information was received from the dutch competent authority explaining that this pr is a duplicate of (b)(4).Both files were reviewed and this was confirmed by the manufacturer.This complaint will be closed cancelled and no additional reports will be submitted.

• Brand Name: COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8775781
• MDR Text Key: 150551475
• Report Number: 1820334-2019-01655
• 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: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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-11.0-100-DLT-EF-ST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 53 YR