The sheath 4fc12 with lot number 76599 was returned and analyzed.Visual inspection showed the shaft was intact with no apparent issues; the air ingress reported issue could not be reproduced.Multiple aspirations/injections were performed without air bubbles or leaks; and the hemostatic valve was leak tight.A pressure test did not show any leak on the shaft, side tube or hemostasis valve.In conclusion, the reported air ingress was not confirmed through testing.The sheath passed the returned product inspection as specification.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, when the balloon catheter was inserted into the sheath, air ingress was observed.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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