Manufacturers ref# (b)(4).Summary of investigational findings: the customer experienced a difficult deployment.The filter was deployed eventually.The patient suffered no adverse effects from the filter.Jugular introducer with protection sheath, introducer sheath, introducer dilator and stop cock were provided for product evaluation.Blood/biological matter was present.At first, it was not possible to get the grasping hook out because of hardened blood/contrast material.After some time, the function was obtained and no nonconformances could be found.It was possible to attach and release a celect-pt filter.Per the product evaluation, the likely cause for the reported event could be hardened blood/contrast or excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Review of device history record showed no evidence to suggest that the device was not manufactured according to specification.According to instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information and product evaluation a likely cause is that tension made it difficult to release the filter.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr 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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