A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak is consistent with damage during use.The ifu states, do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.
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