Product event summary: the sheath, 4fc12 with lot number 57817 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.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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