Sorin group received a report that the stylet was difficult to extract.There was no report of patient injury.The involved unit was discarded, and therefore not returned for evaluation but another unit from the same lot was returned to sorin group usa for evaluation.Evaluation of the returned unit was able to reproduce the issue of difficulty removing the stylet when tested under dry conditions but once flushed, the stylet could be removed with no difficulty.The sorin vent catheter instructions for use instruct the user to "remove the stylet from the catheter and flush the catheter" prior to use.Sorin group initiated a capa in response to this issue.The capa investigation led to the conclusion that the issue was caused by a problem with the surface finish on the stylet.A review of the tubing specification revealed that the surface finish description was not specific enough to ensure the functional requirements were met.Therefore the specification was updated to call out the specific surface finish standard required and this update was communicated to the supplier of the tubing to ensure proper implementation.No further actions are deemed necessary at this time.
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