It was reported that during a cryo ablation procedure, a leak was observed on the sheath.It was noted that air was aspirated over the side port when in the left atrium.The sheath was replaced with resolve, and 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 sheath, 4fc12 with lot number 80848 was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking, the valve was torn.In conclusion, the sheath failed the return 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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