THAL-QUICK CHEST TUBE TRAY
Received Sep 23, 2008 · Event occurred Aug 5, 2008
Report 1820334-2008-00521 · MDR key 1179643
Device
Generic name
Dqr Cannula, Catheter
Manufacturer
Cook, Inc.Model number
NACatalog number
C-TQTSY-1600
Lot number
UNK
Product problems
- Material Frayed
- Material Separation
- Unraveled Material
- Device, removal of (non-implant)
Patient
*
- Foreign body, removal of
- Surgical procedure, additional
Narrative
Description of Event or Problem
USING STERILE SELDINGER TECHNIQUE, A 16 FR CHEST TUBE WAS BEING INSERTED INTO THE LEFT CHEST OF THE PT. AS THE DILATORS WERE BEING USED TO ENLARGE THE ENTRY SITE OVER THE WIRE, THE WIRE WAS NOTED TO BE FRAYED AND UNWINDING. THE WIRE WAS REMOVED FROM THE PT, IN TOTAL, AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADD'L INFO REC'D: THE WIRE DID FRAY AND SEPARATE AND WAS SUBSEQUENTLY REMOVED, INTACT, FROM THE PT. NO ADVERSE OUTCOME WAS NOTED FOR THE PT.
Additional Manufacturer Narrative
NO PROD WAS RETURNED TO ASSIST WITH THIS INVESTIGATION; THEREFORE, WE WERE NOT ABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. HOWEVER, BASED ON THE INFO PROVIDED, IT IS POSSIBLE THE DEVICE MAY HAVE MET WITH RESISTANCE BEYOND ITS INTENDED DESIGN. OUR QC DEPT INSPECTS THIS DEVICE FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS AND VERIFIES THE CURVE CONFIGURATION 100% PRIOR TO FURTHER PROCESSING. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS WERE NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.