MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

Product code: lrc, instrument, ent manual surgical.(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, instructions for use (ifu), and manufacturing instructions of the product was conducted.There is no evidence to suggest the device was not manufactured to current specifications.It is possible that a higher pressure was exerted throughout the balloon than intended, causing the balloon to appear porous and require replacement.Based on the information provided without the returned complaint device, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

Event Description

During an endotracheal tube replacement procedure due to a porous balloon, the reporter lists bilateral pneumothorax and cardiac arrest as consequences.Additional information received on 12jan2016 determined this event to be reportable: according to the initial reporter, the patient required an external cardiac massage and bilateral drainage.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5822218
• MDR Text Key: 50432479
• Report Number: 1820334-2016-00053
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-14.0-83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 07/26/2016
• 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): Other