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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Concomitant products ¿ #3: 37fr left sided double lumen mallinckrodt endobronchial tube, covidien.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.

Event Description

It was reported that a cook airway exchange catheter separated into three segments during a left upper lobectomy and radical lymph node dissection under video-assisted thoracoscopy.A (b)(6) year-old man experienced left chest wall pain off and on with productive cough that had developed for two months.General weakness and poor appetite were also noted.Physical examination on this admission was unremarkable, however chest x-ray and computed tomography demonstrated a 4.3 cm soft-tissue density mass in the upper left lobe of the lung in favor of tumor growth.Fiberbronchoscopy was performed under local anesthesia and specimens were collected: cytology and pathology revealed pulmonary carcinoma.An upper left lobectomy and radical lymph node dissection under video-assisted thoracoscopy was scheduled for the following day.The routine preoperative assessment and examinations were normal, except that the patient was anemic (hemoglobin, 11.8 g/dl).Preoperative airway assessment revealed limited mouth opening (2 fingers held vertically), with the prominent and sharp upper right maxillary canine, but full range of neck flexion and extension, and an appropriate thyromental distance.On arrival at the operating theater, after standard monitors were applied, induction was achieved by total intravenous anesthesia with initial effect site concentration of 4.0 ¿g/ml of propofol and fentanyl 200 ¿g.After rocuronium 50 mg for muscle relaxation, intubation of a 37 fr, left-sided double lumen endotrachial tube (dlt) from another manufacturer was attempted.At the first three attempts, the dlts were all intubated into trachea with ruptured cuff torn by the teeth.The upper right maxillary canine was dislodged at the third time.At the fourth attempt, the dlt was successfully intubated and secured at 28 cm at the right angle of the mouth with adhesive tape.Flexible bronchoscopy was performed to confirm the dlt position at appropriate depth.Anesthesia was maintained with 60% oxygen/air mixture, continuous infusion of propofol, and thoracic epidural analgesia (1.5% lidocaine 10 ml and fentanyl 50 ¿g as loading dose; 0.25% bupivacaine 3.6¿7.0 ml/h as maintenance dose).The operation proceeded uneventfully.At the end of the surgery, replacement of a dlt with a single lumen endotrachial tube (slt) was intended with the use of an airway exchange catheter (aec) given concern of potentially difficult reintubation.A well-lubricated 11 fr, 83 cm, cook aec was placed carefully through the tracheal lumen of dlt to the 25-cm mark at the teeth.Severe resistance was met when an attempt to withdraw the dlt over the aec was made, which stretched, snapped and was then pulled out of the trachea along with the dlt.At that time, the broken end of the aec was noted.Direct laryngoscopy revealed the distal part of aec (15 cm-mark to distal end) left between vocal cords and the middle part (15 to 32 cm-mark) at the right retromolar trigone.Both segments were retrieved with magill forceps.Then, a fresh 7.5-mm slt was repositioned subsequently under direct vision of laryngoscopy.There were no further adverse events, such as hypoxemia or tracheobronchial trauma.At postoperative intensive care unit, chest radiograph showed no new lesion, such as aspiration or foreign body.The patient was then weaned from mechanical ventilation soon after the surgery and uneventfully discharged one week later.Literature citation: wu, h., tai, y., wei, l., cheng, h.And ho, c.(2017).Bronchial lumen is the safer route form an airway exchange catheter in double-lumen tube replacement: preventable complication in airway management for thoracic surgery.Journal of thoracic disease, 9(10), e903-e906.Doi: http://dx.Doi.Org/10.21037/jtd.2017.08.163.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.In the literature article ¿bronchial lumen is the safer route for an airway exchange catheter in double-lumen tube replacement: preventable complication in airway management for thoracic surgery¿, it was reported that a cook airway exchange catheter (rpn: c-cae-11.0-83 ; lot: unknown) separated.The authors report the following: a 71-year-old male (height 157 cm, weight 64 kg; asa class iii) experienced left chest wall pain off and on with productive cough that had developed for two months.General weakness and poor appetite were also noted.His past history was unremarkable except for essential hypertension and type 2 diabetes mellitus.Physical examination on this admission was unremarkable, however chest x-ray and computed tomography demonstrated a 4.3 cm soft-tissue density mass in the upper left lobe of the lung in favor of tumor growth.Fiberbronchoscopy was performed under local anesthesia and specimens were collected: cytology and pathology revealed pulmonary adenocarcinoma.A video-assisted thoracoscopic surgery (vats) for left upper lobectomy was scheduled for the following day.The routine preoperative assessment and examinations were normal, except that the patient was anemic (hemoglobin, 11.8 g/dl).Preoperative airway assessment revealed limited mouth opening (2 fingers held vertically), with the prominent and sharp upper right maxillary canine, but full range of neck flexion and extension, and an appropriate thyromental distance.On arrival at the operating theater, after standard monitors were applied, induction was achieved by total intravenous anesthesia with initial effect site concentration of 4.0 g/ml of propofol and fentanyl 200 g.After rocuronium 50 mg for muscle relaxation, intubation of a 37 fr, left-sided double lumen endotracheal tube (dlt) from another manufacturer (mallinckrodt endobronchial tube, covidien, ireland) was attempted.At the first three attempts, the dlts were all intubated into trachea with ruptured cuff torn by the teeth.The upper right maxillary canine was dislodged at the third time.At the fourth attempt, the dlt was successfully intubated and secured at 28 cm at the right angle of the mouth with adhesive tape.Flexible bronchoscopy was performed to confirm the dlt position at appropriate depth.Anesthesia was maintained with 60% oxygen/air mixture, continuous infusion of propofol, and thoracic epidural analgesia (1.5% lidocaine 10 ml and fentanyl 50 g as loading dose; 0.25% bupivacaine 3.6¿7.0 ml/h as maintenance dose).The operation proceeded uneventfully.At the end of the surgery, replacement of the dlt with a single lumen endotracheal tube (slt) was intended with the use of an airway exchange catheter (aec) given concern of potentially difficult reintubation.A well-lubricated 11 fr, 83 cm, cook aec was placed carefully through the tracheal lumen of dlt to the 25-cm mark at the teeth.Severe resistance was met when an attempt to withdraw the dlt over the aec was made, which stretched, snapped and was then pulled out of the trachea along with the dlt.At that time, the broken end of the aec was noted.Direct laryngoscopy revealed the distal part of aec (15 cm-mark to distal end) left between vocal cords and the middle part (15 to 32 cm-mark) at the right retromolar trigone.Both segments were retrieved with magill forceps.Then, a fresh 7.5-mm slt was repositioned subsequently under direct vision of laryngoscopy.There were no further adverse events, such as hypoxemia or tracheobronchial trauma.At postoperative intensive care unit, chest radiograph showed no new lesion, such as aspiration or foreign body.The patient was then weaned from mechanical ventilation soon after the surgery and uneventfully discharged one week later.Reviews of the complaint history, instructions for use (ifu), and quality control 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: "order number: (b)(4) (inner diameter: 2.3mm) - used for: for use in replacement of endotracheal tubes whose inner diameter (id) is 4 mm or larger." "order number: (b)(4) (inner diameter: 2.3mm) - used for: for use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (id) is 4mm or larger." endotracheal tube exchange.Note: it is recommended that a sterile lubricant be applied to the orifice of the endotracheal tube prior to introduction of cae catheter intended use.The cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.Based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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: 12281574
• MDR Text Key: 265212602
• Report Number: 1820334-2021-01925
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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-11.0-83
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• 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
• Treatment: LARYNGOSCOPE.; MAGILL FORCEPS.; LARYNGOSCOPE; MAGILL FORCEPS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 64 KG