MAUDE Adverse Event Report: COOK INC COOK DOUBLE LUMEN EXTRA FIRM 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

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 in the literature "snapping of cook exchange catheter with subsequent dislodgement in a double- lumen endotracheal tube" that a cook double lumen extra firm airway exchange catheter separated during use.A (b)(6) male patient was admitted to the user facility due to pneumonia and the need for tracheal intubation for respiratory failure.They were transferred from the intensive care unit (icu) to the operating room (or) to undergo video-assisted thoracoscopy.Initially, an 8.0 single lumen tracheal tube was in place and after inducing anesthesia with sevoflurane, the cook exchange catheter was advanced through the tracheal tube to the 30 cm mark.The tracheal tube was withdrawn, and the exchange catheter was threaded through the bronchial lumen of a double-lumen endotracheal tube.At the 20 cm mark, the double-lumen endotracheal tube met mild resistance, and was then "inserted to 29 cm at the patient¿s lips".Severe resistance was met when attempting to pull the cook exchange catheter from the double-lumen endotracheal tube.At this point, the catheter stretched and snapped.The broken end was roughly 2 cm into the endotracheal tube and could not be retrieved with a hemostat.The double-lumen endotracheal tube and catheter fragment were removed.Direct laryngoscopy was performed.A 7.5 single-lumen tracheal tube was placed followed by a 41f double-lumen endotracheal tube with proper positioning of lung isolation confirmed by auscultation and fiberoptic bronchoscopy.Video-assisted thoracoscopy was performed without complication and at the end, a single-lumen 8.0 tracheal tube was placed after removal of the double-lumen tube.The author's describe that in this case, the double-lumen tube was caught at the glottic opening.During attempting insertion of the double-lumen endotracheal tube further into the trachea, it kinked and bent the airway exchange device inside it.The double-lumen endotracheal tube was "coiled in the hypopharynx", and the kink prevented removal of the exchange catheter.Pulling the catheter resulted in it separating.Schulte, t.E,.And tinker, j.H.(2007).Snapping of cook exchange catheter with subsequent dislodgement in a double-lumen endotrachial tube.Anesthesia & analgesia, 105(4), 1174-1175.Doi: http://dx.Doi.Org/10.1213/01.Ane.0000278125.87903.9b.

Manufacturer Narrative

Investigation ¿ evaluation.An adverse event at the (b)(6) medical center involving a cook double lumen extra firm airway exchange catheter (rpn: c-cae-11.0-100-dlt-ef; lot#: unknown) was reported via the literature article: schulte, t.E., & tinker, j.H.(2007).Snapping of cook exchange catheter with subsequent dislodgement in a double-lumen endotracheal tube.Anesthesia and analgesia, 105(4), 1174¿1175.Https://doi.Org/10.1213/01.Ane.0000278125.87903.9b.The authors report the following event: ¿a 73-year-old man, admitted for pneumonia and requiring tracheal intubation for respiratory failure, was transferred directly from the intensive care unit to the operating room to undergo video-assisted thorocoscopy [vats].An 8.0 single lumen tracheal tube was in place.After inducing anesthesia with sevoflurane, a cook exchange catheter was placed through the 8.0 tracheal tube to the 30-cm mark.The tube was withdrawn, and the exchange catheter threaded through the blue bronchial lumen of a 41f sheridan double-lumen endotracheal tube.The double-lumen endotracheal tube was met with mild resistance at 20 cm and then inserted to 29 cm at the patient¿s lips.Severe resistance was met when attempting to pull the cook exchange catheter out of the double-lumen endotracheal tube and the exchange catheter stretched and then snapped.The broken end of the exchange catheter was 2 cm into the double-lumen tube and could not be reached with a hemostat.¿ ¿the double-lumen endotracheal tube was completely withdrawn along with the broken exchange catheter.Direct laryngoscopy was performed and a 7.5 single-lumen tracheal tube was initially placed, and then a 41f double-lumen endotracheal tube was placed with proper position of lung isolation confirmed with auscultation and fiberoptic bronchoscopy.The video-assisted thorocoscopy was then performed without complication.At the end of the case, a single-lumen 8.0 tracheal tube was placed after removal of the double-lumen tube¿¿ ¿in this case, the double-lumen tube was caught at the glottic opening.When attempting to insert the double-lumen endotracheal tube further into the trachea, the double-lumen endotracheal tube kinked and bent the airway exchange device inside it as well.The double-lumen endotracheal tube was actually coiled in the hypophaynx and the kink in the tube prevented removal of the exchange catheter and pulling the catheter caused it to break.¿ no other adverse events were reported.Reviews of the documentation including the 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 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 provided.As adequate inspection activities have been established and no other lot related evidence is available, it was concluded that there is no evidence that nonconforming product exists in house or in field.The evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification.Cook also reviewed product labeling.The current ifu provided with the set was reviewed as is c_t_cae_rev6 which includes the following: order number: c-cae-11.0-83: for use in replacement of endotracheal tubes whose inner diameter (id) is 4mm or larger (inner diameter: 2.3mm) c-cae-11.0-100-dlt-ef: for use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (id) is 4mm or larger c-cae-11.0-100-dlt-ef-st (inner diameter: 2.3mm).Warnings: -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.Endotracheal tube exchange: 1.Before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be replaced, confirm correct endotracheal tube position.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.A clinical evaluation of the event concluded that patient anatomy, inadvertent user error or device failure were possible contributing factors.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: COOK DOUBLE LUMEN EXTRA FIRM 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: 12338780
• MDR Text Key: 267143964
• Report Number: 1820334-2021-02004
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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-11.0-100-DLT-EF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• 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: 41F DOUBLE-LUMEN ENDOTRACHEAL TUBE.; 41F SHERIDAN DOUBLE-LUMEN ENDOTRACHEAL TUBE.; 7.5 SINGLE-LUMEN TRACHEAL TUBE.; 8.0 SINGLE LUMEN TRACHEAL TUBE.; FIBEROPTIC BRONCHOSCOPE.; LARYNGOSCOPE.; SINGLE-LUMEN 8.0 TRACHEAL TUBE.; 41F DOUBLE-LUMEN ENDOTRACHEAL TUBE; 41F SHERIDAN DOUBLE-LUMEN ENDOTRACHEAL TUBE; 7.5 SINGLE-LUMEN TRACHEAL TUBE; 8.0 SINGLE LUMEN TRACHEAL TUBE; FIBEROPTIC BRONCHOSCOPE; LARYNGOSCOPE; SINGLE-LUMEN 8.0 TRACHEAL TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male