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

Model Number N/A

Device Problem Break (1069)

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

Event Date 12/14/2021

Event Type  Injury  

Event Description

It was reported a cook double lumen extra firm soft tipped airway exchange catheter separated.During an endotracheal tube (ett) exchange, as the user was advancing the new ett, the catheter separated.Subsequently, the catheter and ett were removed immediately and the separated portion of the catheter was found in the ett.A chest x-ray was performed to ensure no portion of the catheter remained in the patient.No other adverse effects were reported for this incident.

Manufacturer Narrative

Pma/510(k) #: exempt.Occupation: admin/ manager.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, d10.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.

Event Description

In additional information received on 21dec2021, it was reported that the endotracheal tube used was from another manufacturer.In order to complete the procedure, the operator extubated the newly placed endotracheal tube from the trachea of the patient and re-intubated with a new endotracheal tube via video laryngoscope.It was confirmed that a high pressure oxygen source was not used with the device during the procedure.

Event Description

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

Manufacturer Narrative

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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: on 15dec2021, (b)(6) hospital reported to cook a cook double lumen extra firm soft tipped airway exchange catheter (rpn: c-cae-14.0-100-dlt-ef-st; lot#: 13683733) separated during an endotracheal tube (ett) exchange.The airway exchange catheter (aec) was used to aid in endotracheal tube (ett) exchange.During the procedure, when attempting to advance the new ett over the aec, the catheter fractured.The user immediately removed the ett from the patient and found the separated aec portion contained in the ett.The user then obtained a video laryngoscope to successfully complete the ett exchange.A chest x-ray was obtained to ensure no device fragments were retained in the patient.It was confirmed that a high-pressure oxygen source was not used with the device during the procedure.Reviews of the complaint history, quality control procedures, device history record (dhr), and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer provided images to aid in the investigation.The flexible distal end of the catheter was observed to be broken from the rest of the device.A supplier investigation was performed for the failure mode: the manufacturing lot identified for this complaint was (b)(4), produced on 24nov2020.No scrapped product was reported.Cpt performed tensile and elongation testing on the shaft and flexible tip.There are not any indications from a review of the lot data that this product failed to meet specifications.Storage conditions can cause this material to deteriorate over time resulting in a brittle failure as described in the complaint.Additionally, 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 records (dhr) for the reported complaint device lot 13683733 and the related subassembly lot sa13600382 found no non-conformances that could have contributed to the reported failure.It should be noted that no other complaints are associated with the final product lot.Based on the dmr, the dhr, and with no product return, cook was not able to find evidence that the deice was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu) c_t_cae_rev6 were reviewed for the information related to reported failure mode.Per the ifu: "device description order number: (b)(4).Used for: for use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (id) is 5mm or larger.Endotracheal tube exchange.6.¿ note: it is recommended that a sterile lubricant be applied to the tip of the endotracheal tube prior to advancing the tube.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred¿.Based on the information provided, examination of device photos and the results of the investigation, a definitive root cause could not be determined.It is possible that this failure could have been due to a component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 DOUBLE LUMEN EXTRA FIRM SOFT TIPPED 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: 13120388
• MDR Text Key: 284465593
• Report Number: 1820334-2021-02757
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002364028
• UDI-Public: (01)00827002364028(17)240112(10)13683733
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-14.0-100-DLT-EF-ST
• Device Lot Number: 13683733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 02/14/2022; 09/20/2022
• Supplement Dates FDA Received: 02/14/2022; 04/01/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: ENDOTRACHEAL TUBE (UNKNOWN MANUFACTURER).; MALINKRODT ET TUBE, MEDTRONIC.; RUSCH ET TUBE, TELEFLEX, INC.
• Patient Outcome(s): Required Intervention