Product event summary: the 4fc12 sheath with lot 0010066558 was returned and analyzed.Visual inspection of the sheath showed the shaft was intact with no apparent issues.Performance testing with the leak tester revealed the pressure decay was in an acceptable range.The shaft and valve were leak tight with no apparent issues.Several flushes and aspirations were performed without issues while the balloon catheter was inserted.There was no blockage along the shaft and the shaft and side port were leak tight.In conclusion, the reported air ingress issue was not confirmed through testing.The sheath passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.
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