Product event summary: the data files and sheath, 4fc12 with lot number 99850 were returned and analyzed.The data files showed multiple applications were performed on the date of the event with no system issue.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 and the valve was torn.In conclusion, the reported issue was confirmed through testing.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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