Product event summary: the sheath, 4fc12 with lot number 75381, was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked at 2.6 inches from the tip.Flushing/air aspiration testing did not show any air passing through the tube or expelled from the distal tip.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk was suspected to be torn.In conclusion, the reported valve issue was confirmed through testing.The sheath failed the returned product inspection due to a shaft kink and 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 cryo ablation procedure, the sheath was defective.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.It was further clarified that during the cryo ablation procedure, the hemostatic valve was leaking.The sheath was replaced with resolve.
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