Manufacturer ref# (b)(4).Summary of investigational findings: after unsheathed, the filter would not release, when pressing the release button.It released when half-way re-sheathed, but needed shaking to get out of the sheath.The shaking caused the filter to tilt, but it was left in the patient without any harm reported.No device was returned for analysis and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the difficulties in releasing the filter from the jugular introducer.The instructions for use supplied with the uni device specify in detail how to reload the filter from the femoral to the jugular introducer and how to properly release the filter by pushing the release button completely.The ifu also note that excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, 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 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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