Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the filter was difficult to release - the delivery system had to be rotated to finally release the filter once the blue button was pushed.No product nor imaging was available for investigation and based on the limited information provided, the exact reason for the difficulties encountered, when attempting to release the filter from the jugular introducer cannot be determined.The instructions for use specifies to press the release button completely and to keep slight back tension on the introducer, when releasing the filter, but it also specifies that excessive back tension applied to the system during attempted filter release may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure that this type of device is 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 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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