Product event summary: the sheath 4fc12 with lot number 0010292316 was returned and analyzed.Visual inspection showed the device was full of coagulated blood inside.Performance test with sentinel blackbelt leak tester revealed the pressure decay, which is much more than acceptance range.The pressure test after dissection found the hemostatic valve was leaking; it is suspected that the valve disk is torn.Further dissection did not show any leak along the shaft in the handle.In conclusion, the reported air ingress and hemostatic valve issue was confirmed through testing.The sheath failed the returned product inspection.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, after the sheath was inserted, air was constantly being aspirated through the sideport.It was suspected that the sideport valve was broken.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
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