Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that the filter did not deploy properly.No other information was provided.Because no adverse events were reported it is assumed that the filter was withdrawn back into the jugular introducer and removed, and a new device was used instead.It was assessed that because no non-conformances were detected, there is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.According to the instruction for use 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.Based on the very limited information provided it is unknown what caused the filter to be unable to deploy.However, if there was excessive tension during deployment this could prevent the filter from being released but this is only speculation.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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