The graft sample was returned and evaluated to determine the cause of the complaint.A tactile inspection was performed per the manufacturing procedure and it was noted that the graft had a small hard spot on one end as compared to the rest of the returned graft.The thickness of the graft was normal.Hard spots are inspected for during the manufacturing process.In this case it appears that the manufacturing operator may not have detected the hard spot in the material during the inspection.A review of the manufacturing procedure indicates that the process of inspection requires the manufacturing operators to conduct a tactile inspection on the entire length of the graft.The test procedure instructs the following regarding the tactile inspection: lightly run finger tips along the length of the graft while gently squeezing the graft between the finger and thumb.Feel for any variation in stiffness of the graft.Feel for any hard rings within the graft.Feel for any soft spots within the graft.Flixene eptfe vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.The instructions for use (ifu) states complications that may occur in connection with the use of any vascular graft include, but are not limited to: thrombosis, stenosis, formation of pseudoaneurysm due to excessive needle punctures, peri-graft hematoma formation, peri-graft seroma formation, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, steal syndrome, loss of limb or possible death.
|