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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC.THAL-QUICK CHEST TUBE TRAYDQR CANNULA, CATHETER

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COOK, INC. THAL-QUICK CHEST TUBE TRAY DQR CANNULA, CATHETER   Back to Search Results
Catalog Number C-TQTSY-2400
Device Problems Unraveled material; Other (for use when an appropriate device code cannot be identified)
Event Date 06/15/2009
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

We were advised that the wire unraveled within the patient. Upon placement of the chest tube, the clinician realized she could not remove the inner-cannula and guidewire due to the unraveling. In an effort to withdraw the cannula/wire assembly, the clinician had to use a great deal of force, which resulted in removal of the entire chest tube assembly. The patient had frank pus that was spilling during removal of the chest tube. Once the chest tube assembly was removed from the patient, the unraveled guidewire was found exiting one of the distal holes of the chest tube. Information was provided that this has previously occurred; however, it does not occur when the needle is in situ, but rather on the last step of the procedure when the chest tube is in place. There was no guidewire resistance when passing the dilators over the wire. It is possible this was a difficult pleural space. The patient outcome was not provided.

 
Manufacturer Narrative

Product was returned in a used and damaged condition. From the appearance of the device it is suspected that the wire guide was caught and elongated. As information was provided that this situation did not occur when the needle is in situ, but rather on the last step of the procedure, there are two possible scenarios: it is possible that contact was made with the wire guide when making the small incision and if the wire guide and the chest tube inserter were not removed together, per the attached instructions for use. It is stated that the dilators and the chest tube assembly should be advanced into the plural space in the same line as the wire guide to avoid kinking of the wire guide. Any kinking of the wire guide increases the possibility of elongation and unraveling. We will continue to monitor for similar complaints.

 
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Brand NameTHAL-QUICK CHEST TUBE TRAY
Type of DeviceDQR CANNULA, CATHETER
Manufacturer (Section F)
COOK, INC.
bloomington IN 47404
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, manager
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key1486117
MDR Report Key1413957
Event Key1348733
Report Number1820334-2009-00398
Device Sequence Number1
Product CodeDQR
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/15/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2011
Device Catalogue NumberC-TQTSY-2400
Device LOT Number2291015
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/25/2009
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/15/2009
Device Age2 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/15/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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