It was reported that during a cryo ablation procedure, after the sheath was inserted in to the balloon catheter, air ingress occurred indicating damage to the hemostatic valve.The sheath was then 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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Product event summary: the flexcath advance sheath, 4fc12 with lot 76590-012, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issue.Air ingress was reproduced during the pressure and aspiration test when the test dilator was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.It is suspected that the valve disk is torn.In conclusion, the reported issue of air ingress and confirmed through testing.The sheath failed the returned product inspection due to the suspected torn hemostatic valve disk.If information is provided in the future, a supplemental report will be issued.
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