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

Model Number N/A

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 08/28/2017

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

The international customer reported that, during a thoracotomy procedure, the cook airway exchange catheter was employed in the replacing of the intubation tubes.The catheter went into the intubation tube, but reportedly got stuck after 10 cm of depth, and would not advance further into the tube.The catheter was then pulled from the tube, and the patient was reconnected to the respirator.The operator subsequently observed that the respirator had a yellow plastic "mark/piece" [sic] that had peeled off of the exchange catheter.A suction catheter was employed in an attempt to remove it, without success.Another plastic piece from the catheter was also found n the patient's lung, and it took 30 minutes to remove it.The customer confirmed that the product is available for return; however, as of the date of this report, no product has yet been received for evaluation.

Manufacturer Narrative

The product has been returned for evaluation.The reporter indicated that no photos, operating reports, x-rays, or scans will be made available.Additional information was provided on 03oct2017 regarding the reported event.No unintended portion of the device remained inside the patient¿s body.The piece was removed by scope.There were no adverse effects to the patient because of this event.Investigation ¿ evaluation: a review of complaint history, the device history record, drawings, the instructions for use, quality control data, and device specifications has been conducted.A visual inspection of the returned device was also performed.One device was returned for investigation.A visual examination noted scrape marks on the device starting at 2.5cm from the distal tip extending to 5.6cm.The tubing was pin gauged.The distal end and proximal end were pinned and the investigation results indicated that the device was not out of specification.It is not known how the scrape mark occurred on the tubing or if it affected the intended use.Based on the investigation evaluation, there is no indication that a design or process-related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality / device integrity prior to shipping.A review of the device history record did not observe any non-conformances that may have contributed to this reported incident.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against the complaint lot number; 7134177.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and the correct deployment procedure.Per the ifu, ¿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.¿ additionally, the ifu states, ¿before advancing the cook airway exchange catheter into the endotracheal tube to be replaced, confirm correct endotracheal tube position.¿ based on the provided information and the investigation evaluation, the actual root cause is unknown and a conclusion cannot be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor for similar complaints.

• Brand Name: COOK 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: 6894290
• MDR Text Key: 87372522
• Report Number: 1820334-2017-03232
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002058804
• UDI-Public: (01)00827002058804(17)190720(10)7134177
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Date Device Manufactured: 07/20/2016
• 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): Required Intervention