Product event summary: the flexcath advance sheath, with lot 31826, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues; the reported 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, with lot 31826, passed the returned product inspection as per specification.
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