Product event summary: the sheath 4fc12 with lot number 85396 was returned and analyzed.The visual inspection showed the device was intact with apparent issue.After cleaning and sterilizing the sheath, air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking.Further dissection didn't show any leak along the shaft in the handle.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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