Product event summary: the sheath, 4fc12 with lot number 19522 was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking; the valve disk was suspected to be torn.In conclusion, the 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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It was reported that prior to a cryo ablation procedure, air kept coming through the hemostatic valve of the sheath.The side arm was pulled back, without resolve.The sheath was then replaced with resolve.The procedure continued, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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