Additional information: d9, g3, h2, h3, h6.One 8.5f fast-cath introducer sheath was received for evaluation.The dilator was also received.Functional testing did not confirm a fluid leak, however, an air leak was noted in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted on the distal face of the seal, at both ends of the seal slit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
|