Product event summary: the data files and sheath, 4fc12 with lot number 57838 were returned and analyzed.The data files showed at least 9 injections were performed with a balloon catheter on the date of the event without any system notice triggered.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 air ingress was confirmed during 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.
|