Event summary: visual inspection of sheath showed the showed the device was full of blood.After removing and sterilizing the sheath, air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheaths.The hemostatic valve was leaking.It was suspected that the valve disk was torn.Further dissection did not show any leak along the shaft in the handle.In conclusion, the reported hemostasis valve leak issue was confirmed through testing for the returned sheath.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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