Manufacturers ref# (b)(4).Summary of investigational findings: a filter was deployed during a filter placement procedure, but the filter legs were wrapped up intertwined and the filter was therefore retrieved ((b)(4)).A second attempt to implant a new filter during the procedure failed because the filter would not deploy from the sheath at all, and the device was therefore withdrawn from the patient ((b)(4)).Lastly, the user tried with a third attempt, and the filter was implanted successfully.No adverse effects on the patient was reported due to this occurrence.Two devices with missing parts were returned for evaluation.No parts of the returned product were marked with the belonging pr#.The returned parts belonging to this pr (b)(4) ) were assumed to be a jugular introducer and a celect-pt filter attached to an unknown retrieval set.The jugular introducer was curved, and the red safety button was pushed down.No nonconformances were found on the filter, and filter legs were almost evenly distributed.The diameter of the primary legs, the diameter of the secondary legs and the height between the primary legs and the secondary legs were all measured to be in accordance to specifications.It is not clear how the procedure progressed prior to deployment of the filter, however, ifu warns not to rotate the filter inside the introducer system or inside the vena cava as this may compromise filter performance, which could likely be the cause for the reported event.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.However, there are adequate controls in place to ensure the device was manufactured to specifications.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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