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

Model Number N/A

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

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

Event Type  Injury  

Event Description

It was reported to cook regarding an event involving an arndt airway exchange catheter set that was discussed in the literature article, failure of the air-q laryngeal airway to facilitate exchange with the arndt airway exchange catheter, by william kirke rogers, md and ron abrons, md.(can j anesth/j can anesth (2016) 63:1297¿1298)."a 208-kg (body mass index 70 kg) woman with tracheal deviation secondary to a thyroid mass presented for elective thyroidectomy.She had previously undergone awake flexible bronchoscopic intubation for other operations and reported severe anxiety and nightmares related to the experience.She wished to avoid repeat awake intubation.The surgical service requested utilization of a nim trivantage emg ett (medtronic, minneapolis, mn, usa) for intraoperative monitoring of the recurrent laryngeal nerve.Because of the patient¿s obesity and tracheal deviation, we thought that induction of anesthesia without a controlled airway would be unsafe.We did not think, however, that an appropriately sized nim ett (with the bulk of its conductive electrodes and wires) would pass directly through an air-q.We felt quite comfortable offering the patient awake air-q placement with exchange catheter-facilitated conversion to a nim tube after induction of general anesthesia.Awake placement of a size 4.5 air-q was uneventful.After demonstration of successful positive-pressure ventilation, general anesthesia was induced.A flexible intubating bronchoscope was advanced easily through the aaec bronchoscopic swivel adapter and air-q into the trachea.The provided guidewire was then passed through the working channel and into a bronchus.The flexible scope was withdrawn over the wire.The tapered exchange catheter was then threaded over the wire and into the air-q, but advancement became impossible past the 25 cm mark (measured at the end of the bronchoscopic swivel adapter).Our assumption was that the exchange catheter was caught on the tracheal wall.The air-q was therefore slowly removed while attempts were made to advance the catheter while keeping the wire intact.A video laryngoscope (vl) was then placed in the patient¿s mouth, revealing that the exchange catheter and guidewire had been pulled out of the airway during the attempted exchange procedure.The vl view of the glottis allowed successful direct placement of the nim ett.On later re-creation of the above scenario in a simulation laboratory, we realized that the tapered tip of the arndt exchange catheter likely became wedged in the narrow cleft between the inner sidewall and the small ¿¿elevation ramp¿¿ in the middle of the laryngeal surface of the air-q (see figure and the video available as electronic supplementary material).This ramp is intended by the manufacturer to facilitate intubation by directing an endotracheal tube anteriorly toward the laryngeal inlet.In our case, however, the exchange catheter likely became entrapped in the cleft, preventing advancement of the catheter into the trachea and resulting in misdiagnosis of tracheal wall impingement." no other adverse effects were reported for this incident.Work cited: rogers, w.K., abrons, r.Failure of the air-q® laryngeal airway to facilitate exchange with the arndt airway exchange catheter.Can j anesth/j can anesth 63, 1297¿1298 (2016).Https://doi.Org/10.1007/s12630-016-0712-0.

Manufacturer Narrative

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: (b)(6) hospital and clinic (united states) reported an issue with an arndt airway exchange catheter set (rpn: c-cae-14.0-70-lma, lot: unknown) on (b)(6) 2022.The customer stated that they experienced difficulty advancing the catheter during an awake placement of a supraglottic airway.The customer believes that the tapered tip of the catheter likely became wedged in the narrow cleft between the inner sidewall and the small ¿elevation ramp¿ in the middle of the laryngeal surface of the air-q (customer ran simulation).The customer commented that lubricating the tapered tip will help prevent this problem.They also feel that this event can be avoided by measuring the exchange catheter depth prior to inserting the flexible scope.No other adverse effects were reported for this incident.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, 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 prevent nonconforming material from leaving house.A review of the device history record (dhr) could not be conducted due to the lack of lot information from the facility.A review of sales to the customer was unable to narrow down a possible lot number.Cook was not able to determine if the product was out of specification, or if nonconforming material remained in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_abe_rev7.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 exchange catheter refer to distance from tip of catheter.Catheter and endotracheal tube should not be advanced beyond the carina.In the precautions section it states: this product should not be used in replacement of endotracheal tubes whose inner diameter is smaller than 5 mm.Care should be taken to maintain wire guide position during placement of exchange catheter.When using an lma, ensure the cuff is properly inflated and breath sounds are present.If possible, confirm the position of the lma by using chemical or electronic capnography.It is recommended that a sterile lubricant be applied to the exchange catheter, bronchoscope, and new endotracheal tube prior to their introduction into patient.In the instructions for use section (lma or endotracheal tube exchange) it states: 3.) advance the soft, flexible end of the wire guide through the working port of the bronchoscope until it is seen to exit the bronchoscope into the patient¿s trachea.Advance the wire guide to the level of the carina.4.) carefully remove the bronchoscope, leaving the wire guide in place in the trachea, exiting the bronchoscopic port.5.) maintaining wire guide position, advance the exchange catheter over the wire guide through the bronchoscopic port and through the lma or endotracheal tube into the trachea.6.) properly position the exchange catheter within the endotracheal tube by aligning the appropriate centimeter mark on the exchange 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.7.) fully deflate the cuff of the endotracheal tube or lma and remove the rapi-fit adapter (if on the exchange catheter) while maintaining position of the exchange catheter.Remove the endotracheal tube or lma, leaving the exchange catheter in place.Note: it is recommended that a sterile lubricant be applied to the tip of the endotracheal tube prior to advancing the tube.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 failure to follow instructions contributed to the reported event.The customer stated that they experienced difficulty advancing the catheter and believed that the tapered tip of the catheter likely became wedged in the narrow cleft between the inner sidewall and the small ¿elevation ramp¿ in the middle of the laryngeal surface of the air-q (customer ran simulation).The customer feels adding a proper amount of lubricant would help to prevent this difficulty.The customer also commented that measuring the exchange catheter properly would also help prevent this difficulty.The instructions pamphlet provided with this product clearly indicates steps to measure the exchange catheter and how to measure properly.The instructions pamphlet also notes that it is recommended to lubricate the catheter prior to advancing the exchange catheter into 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: ARNDT AIRWAY EXCHANGE CATHETER SET
• 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: 15496378
• MDR Text Key: 300705880
• Report Number: 1820334-2022-01548
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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-14.0-70-LMA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 208 KG