Product event summary: the sheath 4fc12 with lot number 0009980228 was returned and analyzed.Visual inspection showed the device was intact with no apparent issue.Air aspiration was reproduced during the aspiration test when the test catheter was introduced through the sheath.The hemostatic valve was leaking; and it was suspected the valve disk was torn.Further dissection didn't show any leak along the shaft in the handle.In conclusion, the reported air ingress was confirmed through testing.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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