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

Model Number N/A

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(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

In the literature article "an underappreciated risk of an airway exchange catheter," a complication with a cook airway exchange catheter was reported.The author reports the following: the device was required for use during a mandibular fixation procedure with postoperative jaw wires.An awake nasal flexible bronchoscopic (fb) technique was used to secure the airway with a competitor's size 8.0 endotracheal tube (ett).There was a moderate amount of dried blood and minor oropharyngeal bleeding, but visualization was adequate, and fb-assisted nasal intubation was uneventful.Approximately two minutes after the ett was secured, there were difficulties with ventilation due to an air leak from a ruptured ett cuff.To facilitate ett exchange, an 83 cm long cook airway exchange catheter (aec) (model: c-cae-19.0-83, cook medical; bloomington, in, usa) was gently advanced inside the ett until resistance was met.Immediately after, two attempts at pulling the ett over the aec were met with resistance preventing the ett from being removed.Subsequently, a competitor's video laryngoscope was cautiously inserted to assess the supraglottic area.As seen in the figure, the tip of the aec had passed through the murphy eye of the ett, and then in a retrograde manner had looped back on itself and kinked in the trachea.Seeing this tortuous path of the aec, we attempted to pull back the aec into the ett.Nevertheless, significant resistance was met because of kinking of the aec at the ett murphy eye.Therefore, under video laryngoscopy guidance, the kinked aec and ett were removed as a unit and the patient was successfully re-intubated orally.The patient was followed up postoperatively for five days, and there were no apparent sequelae." reference: foglia, j., & guy, j.(2019).An underappreciated risk of an airway exchange catheter.Canadian journal of anesthesia/journal canadian d'anesthésie, 67(4), 491¿492.Https://doi.Org/10.1007/s12630-019-01504-7.Doi link: https://doi.Org/10.1007/s12630-019-01504-7.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation university of british columbia (canada) wrote a journal article in which an unknown cook airway exchange catheter (lot unknown) was used.The authors state that the patient was a fifty-six-year-old adult male who obtained isolated facial injuries from a mechanical fall resulting in bilateral anterior mandible fractures and a right condylar fracture.An awake nasal flexible bronchoscopic technique was used to secure the airway with a size 8.0 parker flex-tip (model: h-pfhv-80, parker medical; highlands ranch, co, usa) ett.Approximately two minutes after the ett was secured, there were difficulties with ventilation due to an air leak from a ruptured ett cuff.To make the ett exchange, the customer used an 83 cm long cook airway exchange catheter (model: c-cae-19.0-83, cook medical; bloomington, in, usa) was gently advanced inside the ett until resistance was met.There were two attempts at pulling the ett over the aec, but both attempts were met with resistance.The customer used a glidescope to assess the supraglottic area.The tip of the aec had passed through the ett and had looped back on itself and kinked in the trachea.Seeing this, it was attempted to remove the aec into the ett; however, resistance was met due to the kinking.Due to this, under glidescope guidance, the kinked aec and ett were removed as one, and the patient was successfully re-intubated orally.The date of this event is 23sep2019 and cook became aware of this event on (b)(6) 2022.Reviews of the documentation, including the complaint history, 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 conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to identify this failure mode prior to distribution.A review of the device history record (dhr) could not be conducted due to the lack of lot information from the facility.Cook medical performed an expanded sales regarding the reporting facility; however, the complaint lot was unable to be identified.From the review of the dmr, cook was not able to determine if the product was manufactured out of specification.Cook was not able to determine non-conforming material 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.In the instructions for use section, it states: 1.) before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be replaced, 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, sideported end first into the endotracheal tube to be replaced.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.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 returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.The author stated that during use of the cae catheter, when placing the new tube over the catheter, resistance was met.It was found that the catheter had kinked, and the new tube could not pass past that point.It is possible that the catheter was not advanced correctly, which in turn caused the catheter to kink.It is also possible that not enough lubricant was used to allow easy advancement of the catheter.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.

• 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: 15667962
• MDR Text Key: 302359368
• Report Number: 1820334-2022-01655
• 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: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 02/03/2023
• 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
• Treatment: ETT- PARKER FLEX-TIP #H-PFHV-80, PARKER MEDICAL; LARYNGOSCOPE-GLIDESCOPE 0570-0338,VERATHON MEDICAL
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male