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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): (b)(6).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 that a cook airway exchange catheter broke during a procedure in the intensive care unit (icu).Additional details regarding the event have been requested, but are currently unavailable.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by getter bio-med ltd that a cook airway exchange catheter (c-cae-11.0-83, lot number 13159687) broke during a procedure at belinson hospital in israel.Cook contacted the physician related to the case for additional information who responded that they are very busy in the covid unit and would respond later; however, cook has received no further information at this time.A review of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One airway exchange catheter was returned for evaluation in two segments.The point of separation on each segment was noted to be stretched and deformed.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.A review of the device history record (dhr) for lot 13159687 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot.The evidence from the complaint file, device history record, complaint history, and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The instructions for use (ifu), provides the following information related to the reported failure mode: device description: order number c-cae-11.0-83 (inner diameter: 2.3mm).Used for: for use in replacement of endotracheal tubes whose inner diameter (id) is 4mm or larger.Warnings: -ensure proper sizing of cook airway exchange catheter with 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.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could not be established.The appropriate personnel have been notified.Per the quality engineering 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 AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11265736
• MDR Text Key: 262655225
• Report Number: 1820334-2021-00230
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002067325
• UDI-Public: (01)00827002067325(17)230428(10)13159687
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-11.0-83
• Device Lot Number: 13159687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1