Product event summary: the data files for the date of the reported event and the sheath, 4fc12 with lot 61027, were returned and analyzed.The data files showed an unrelated system notice was received on the date of the case.Visual inspection of the sheath showed the device was intact with no apparent issues.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk is suspected to be torn.In conclusion, the reported air ingress issue has been confirmed through testing.The sheath, 4fc12 with lot 61027, 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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It was reported that during a cryoablation procedure, air was continuously removed from the sheath side port.The sheath was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.The sheath subsequently tested out of specification per the manufacturer's investigation.
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