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

Catalog Number C-CAE-19.0-83

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.The patient required removal of the separated portion of the device to preclude permanent impairment/death.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 a cook airway exchange catheter separated inside of a patient following implantation.It was reported that the device was advanced into a 7.5 mm endotracheal tube to be replaced and while "attempting to remove the 7.5 mm endotracheal tube, the physician completed airway extubation without problems".However, follow-up x-ray imaging completed two days after the procedure found that the device had separated in the patient's trachea.The separated portion was then removed from the patient, presumably by using a fiberscope and forceps.It was also reported that the physician chose to use the device knowing that the date of sterilization had expired, making a reference to "how many days it takes for the product to deteriorate after the date of sterilization expires".The device felt "very hard" upon removal.No other adverse effects to the patient have been reported.

Event Description

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

Manufacturer Narrative

Investigation - evaluation.On (b)(6) 2020, (b)(6) hospital reported an incident involving a cook airway exchange catheter, rpn c-cae-19.0-83.Two days after the physician performed extubation, an x-ray was performed per facility follow-up procedure, which showed a segment of the catheter inside the patient.It was also reported that the physician knew the product was used after the device expiration indicated on the product label.There was no information regarding the patient condition post retrieval of the separated catheter segment.A review of the instructions for use (ifu), manufacturing instructions (mi), quality control and trends was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are current controls including sufficient manufacturing and inspection steps in place to identify this failure mode prior to distribution.A review of the device history record (dhr) and a database search for additional related events were unable to be completed due to a lack of lot information from the user facility.The investigation results found that current process and quality inspection checks are in place to ensure the device functionally and integrity prior to shipment, suggesting that nonconforming product does not exist either in house or in field.No specific issue with this documentation that may have contributed to this failure mode was found.Based on the information provided, no product returned, and the results of the investigation, a definitive root cause could not be established.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.

• 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: 9664870
• MDR Text Key: 189241452
• Report Number: 1820334-2020-00273
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-19.0-83
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention