MAUDE Adverse Event Report: COOK, INC. THAL-QUICK CHEST TUBE SET; CATHETER, IRRIGATION

Catalog Number C-TQTS-1400

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

The supervising staff specialist watched a registrar insert the catheter.The specialist stated that the wire and initial dilator went in smoothly but it wasn't until they used 2nd dilator that they found could not advance properly.When they removed it, they found the dilator tip to be curved and the wire was noted to be kinked.They tried a new kit in a new area of the chest and the same thing occurred.The pt also developed a pneumothorax as revealed on chest x-ray so they had to abandon this technique and insert a formal chest drain via blunt dissection.The specialist that he suspects it could be user error but that her also felt the wire to be a bit flimsy; even though he knows it needs to be, to ensure it doesn't cause any damage inside the pt.The specialist said he will try the product the next few times and see how it goes.The cook sales specialist went through the importance of inserting the dilators in the same angle as what the needle was inserted to prevent wire from kinking (as it states in the instructions for use).

Manufacturer Narrative

(b)(4).Event date: unk as not provided by the reporter.Pneumothorax is not labeled in the ifu.Event is still under investigation.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harder, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4193836
• MDR Text Key: 5097740
• Report Number: 1820334-2014-00494
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: C-TQTS-1400
• Device Lot Number: 4757852
• Other Device ID Number: UDI# (01)00827002057777(17)170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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