Manufacturers ref# (b)(4).Summary of investigational findings: femoral approach was used for filter placement, but introducer sheath kinked when it made the turn in the right iliac vein.The filter was navigated through the tight corner, but the hook of the filter perforated the introducer sheath.The user changed to jugular approach where the filter was retrieved, followed by filter replacement.No adverse effects on the patient has been reported due to this occurrence.An introducer sheath was returned for evaluation.A perforation was found 222 mm from the distal end.Furthermore, several kinks were found 82mm, 102mm, 147mm, 163mm, 222mm and 517mm from the distal end.It is most likely that the introducer sheath kinked due to the patient anatomy.Ifu states that excessive force should not be used to advance the filter through the introducer sheath system.However, it is possible that the user felt difficulty in advancing the filter through the kinked introducer sheath, and therefore felt the need to exert excessive force, leading to the reported event where the filter perforated the introducer sheath.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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