Additional information: d9, g3, h2, h3.One 14f fast-cath introducer sheath was received for evaluation.Functional testing confirmed a fluid leak 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 in at both ends of the distal seal slit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak remains unknown.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
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