Manufacturers ref# pr286525.Summary of investigational findings: it was reported that the filter failed to deploy properly and had to be recovered, but recovery was complicated by laceration to ivc, which was treated by balloon tip not.No product was returned for investigation and without the actual complaint device it may be inappropriate to speculate at what may or may not have caused the difficulties encountered, when attempting to release the filter.However, the instructions for use specify to press the release button completely to ensure proper release of the filter and also, that excessive back tension applied to the system during attempted filter release may prevent the filter from releasing when the release mechanism is activated.No evidence to suggest product was not manufactured according to specifications 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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