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.
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.