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

Model Number N/A

Device Problem Flaked (1246)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.(b)(4).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 the coating of a cook airway exchange catheter fell off during an unknown procedure, resulting in retrieval from the patient during the same procedure.It was also reported that the coating "can be stripped off going through a tube too tight.It is not made out of the same material as a bougie for example", which could potentially result in "getting torn plastic material into patient airway / trachea / lungs".No other adverse effects to the patient have been reported.Additional information regarding event details has been requested but is unavailable at this time.

Manufacturer Narrative

Additional information: d11 - concomitant medical products: covidien shiley endobronchial double lumen tube.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information was received on 23dec2019 indicating that an endobronchial double lumen tube was used during the procedure.The separated coating of the catheter was retrieved by biopsy forceps.

Manufacturer Narrative

Investigation / evaluation: a review of the device history record (dhr), drawing, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One cook airway exchange catheter was returned for evaluation.Upon visual inspection, scrape marks were noticed on the proximal end of the device.A flat spot was noted on the tubing.The side-port appeared uniformed and all markings were visible.There is no evidence to suggest the complaint device was not manufactured to specification.Additionally, a document-based investigation evaluation was performed.The device master record concludes that sufficient inspection activities are in place to identify this failure mode prior to distribution.The dhr for the complaint device lot: (9704275) revealed one related non-conformance for a surface defect in which one device part was scrapped.Cook has concluded the recorded non-conformance does not indicate that the device in question was likely non-conforming and that there is no evidence to suggest that non-conforming product exists either in house or in field.A database search revealed one related event from the same customer for the same failure mode but did not reveal any other complaints associated with the reported device lot.Cook also reviewed product labeling.The airway exchange catheter is supplied with ifu c_t_cae_rev5, which includes in the warnings: "ensure proper sizing of the cook airway exchange catheter within a double-lumen endotracheal tube.Failure to do so may cause small fragments to be shaved off during removal of the cook airway exchange catheter.The ifu states in the device description that a c-cae-19.0-83 is for use in replacement of endotracheal tubes whose inner diameter (id) is 7mm or larger." based on the information provided, inspection of the returned product, and the results of our investigation, a root cause was traced to intentional off-label, unapproved, or contraindicated use.The airway exchange catheter ifu specifies it should be used in replacement of endotracheal tubes whose inner diameter (id) is 7mm or larger.The returned device from the customer is scraped likely indicating that it was used inside a device that could not accommodate it.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.

Event Description

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

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9468059
• MDR Text Key: 179414999
• Report Number: 1820334-2019-03117
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention