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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Almeida, jp, et al.: bronchial injury and pneumothorax after reintubation using an airway exchange catheter.Rev.Bras.Anestesiol.2013; 63(1):107-112.The above referenced journal article reports that a (b)(6) woman presented for bronchoscopy, right video-assisted thoracoscopy, and lung resection for a lung mass.The patient was intubated with an unspecified 8.0 single-lumen endotracheal tube to facilitate bronchoscopy which did not reveal any airway abnormalities.The endotracheal tube was removed after bronchoscopy and direct laryngoscopy was performed to place a 37f dlt; however, an adequate view could not be achieved for advancement of the dlt through the vocal cords.Another 8.0 single-lumen tube was placed.A cook 11f, lubricated, airway exchange catheter (aec) ef extra firm was then inserted, but the tip was not advanced past the distal end of the endotracheal tube.This was verified by observing the depth markings of both the endotracheal tube and the tube exchanger during the insertion.The single-lumen tube was removed, and laryngoscopy was performed while the dlt was easily advanced over the tube exchanger, which was held in place at the operator end.The correct position of the dlt was confirmed with fiberoptic bronchoscopy, both before and after positioning in the lateral decubitus position.The surgery proceeded uneventfully.The patient was turned back to the supine position, the dlt was removed, and a single-lumen tube was placed by using direct laryngoscopy.Bronchoscopy by the surgeons to examine the bronchial stump revealed a 2-cm separation of the membranous portion of the trachea.The patient was extubated with no additional surgical management because there was no air leak from this partial disruption.The postoperative chest x-ray did not reveal any evidence of pneumomediastinum or pneumothorax.The patient made an uneventful recovery and there were no untoward sequelae from this partial tracheal tear.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, documentation, drawings, specifications, and quality control data was conducted during the investigation.This complaint was opened through the discovery of a journal article in which it was reported that a patient experienced a separation of the trachea following use of a cook airway exchange catheter.The device mentioned in the journal was the cook 11 fr.Ef extra firm airway exchange catheter (c-cae-11.0-100-dlt-ef).Cook airway exchange catheters are intended for uncomplicated atraumatic endotracheal tube exchange.Specifically, the c-cae-11.0-100-dlt-ef is used for replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter is 4mm or larger.Review of the article identified c-cae-11.0-100-dlt-ef (g13348) as the device involved.The article stated that, "the tip is of the same extra-firm consistency as the rest of the catheter".It also stated that, "although not yet available at the time of this writing", (i.E.The article), "cook has redesigned the aec ef tube exchanger and has made the leading tip soft, whereas the rest of the exchanger is still firm.This prototype has been successfully used in this institution, with no untoward sequelae.This design is to avoid trauma from the insertion but still have adequate strength for the dlt to be successfully advanced into the trachea." a cook project was initiated in 2005 to replace the extra-firm (ef) tip with a soft tip (sf).Design input requirement: "the flexibility of the distal catheter shaft shall be softer than the proximal portion of the shaft", was verified and these soft-tipped devices have replaced the device used in the journal article.Since the article was from 2007 and information could not be gathered regarding lot number, review of the device master record could not be conducted.The manufacturing documentation and risk analysis surrounding the new soft tipped tube exchangers was reviewed with no notable gaps identified.This investigation could not determine a likely root cause based on the information provided in the journal article.There were multiple instruments (i.E.Laryngoscope, endotracheal tubes, and airway exchange catheter) introduced into the airway prior to identifying the injury.Risk factors for airway disruption were identified in the article and included direct trauma from the endotracheal tube, over-inflation of the cuffs, improper tube size, preexisting airway pathology, abrupt movements by the patient, and use of a firm tube exchanger in the placement of a dlt.The authors reported that a likely cause of the tear was the intubation by the tube exchanger.The authors identified another possible cause of trauma as being the double-lumen tube itself.The cae catheter was not able to be retrieved and examined, and the duration between the occurrence of this incident and filing of the complaint report (10 years) led to reliance on the journal article for the majority of information during the investigation.Therefore, aecs may lead to tracheal trauma but are one of several risk factors.No complaints related to tracheal laceration have been reported for this device since the release of the soft tipped (sf) exchange catheter.The reporting authors indicated that, prototypes of the current device had been successfully used in their institution, with no untoward sequelae.Since the incident occurred over 10 years ago, attempts at communicating with the complaint source were not pursued further.Facts and conclusions pertaining to the incident were presented in the article and no further information was expected to be obtained from the hospital or authors, considering the time that had passed.The device involved in the incident has been replaced with a "soft-tipped" (st) version, and the device involved is no longer available.A risk analysis was completed for organ puncture and/or laceration following the use of c-cae airway exchange catheters and it was concluded that further risk reduction is not necessary at this time.The appropriate personnel have been notified and we will continue to monitor for related complaints.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6654410
• MDR Text Key: 78019692
• Report Number: 1820334-2017-01603
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 01/18/2018
• 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): Other
• Patient Age: 57 DA