Product event summary: the data files and sheath, 4fc12 with lot number 30516 were returned and analyzed.The data files showed multiple injections were performed with an unrelated catheter and showed inflations were not sustained at many injections.Visual inspection of the sheath showed the device was intact with no apparent issues.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve and the valve disk was suspected to be torn.In conclusion, the air ingress issue 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 cryoablation procedure, as the balloon catheter was inserted in the sheath and air aspiration was performed, it was observed that air would continuously leak from the hemostatic valve.It was noted that several syringes were needed to complete the air aspiration.The sheath was then replaced, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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