Product event summary: the flexcath advance sheath, 4fc12 with lot number 03358, and data files were returned and analyzed.The data files did not show any system notices for the date of the reported event.Visual inspection of the sheath showed the shaft was intact with no apparent issues; the reported issue of air ingress could not be reproduced.Multiple aspirations and injections were performed without air bubbles or leaks; the hemostatic valve and valve assembly were leak tight.In conclusion, the reported issue of air ingress was not confirmed through testing.The flexcath advance sheath, 4fc12 with lot number 03358, passed the returned product inspection as per specification.
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