MAUDE Adverse Event Report: COOK, INC. COOK AIRWAY EXCHANGE CATHETER; KTI BRONCHOSCOPE ACCESSORY

Catalog Number C-CAE-11.0-83

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Breathing difficulties (2401)

Event Date 08/21/2014

Event Type  Injury  

Event Description

A patient with a known difficult airway was going to be extubated.The physician decided to use an 11 french cook cae.Using a bronch adapter while the patient was still being ventilated.The doctor says that the markings on the catheter only go to 35cm - the physician likes to go to 25cm at the mouth but couldn't see the numbers at the mouth nor could they be seen at the top of the bronch adapter.The physician was trying to guess on his depth since the markings only go to 35cm and could not see how deep in the patient's airway the device was.It turns out the device was only approximately 15cm in the patient's airway and the catheter fell out.Unfortunately, the patient did require reintubation but could not be and ended up having a cricothyrotomy.The physician feels if the cae had a higher depth markings that this would help with the safety of the product as a double check to let them know how deep the catheter is.The physician stated if markings up to 65cm would be helpful.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: KTI BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4218555
• MDR Text Key: 4998544
• Report Number: 1820334-2014-00554
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-11.0-83
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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