Product event summary: visual inspection of the sheath, 4fc12 with lot number 48985 showed the device was intact with no apparent issues.Deflection worked as per specification.Multiple aspirations/ injections were performed without air bubbles or leaks through the hemostatic valve when a test balloon catheter was introduced through the sheath.The hemostatic valve was leak tight.In conclusion, the reported issue was not confirmed through testing for the returned product.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 inserting the balloon catheter into the sheath, there was air ingress.It was further reported that the lips of the sheath valve were not as soft as expected.The case was completed with cryo.No patient complications have been reported as a result of this event.
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