Description of event according to initial reporter: for a filter placement the cook celect platinum navalign uniset vena cava filter set, g34505, was used.The physician was going in a jugular approach.There was trouble with the blue button getting stuck.Physician went to deploy and had not pushed the deployment button and he noted that the filter was too low.He resheathed, moved the device up then noted it was tilted slightly.When he went to resheath it again it would not resheath and made an audile pop noise and the filter deployed.The physician noted it looked as thought the hook had straightened out.As he [the physician] felt the filter was okay where it was at he decided to leave it.Patient outcome: it is planned to remove the filter in a few months.It was confirmed that there was no harm to the patient.
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404.Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.Difficulties releasing the filter was reported; the blue button got stuck and the filter was slightly tilted when released.When attempting to resheath the tilted filter, it made an audile pop noise and the filter deployed.Physician decided to leave it and planned to remove it in few months.Only femoral and jugular introducer were returned.The jugular introducer was slightly curved, but worked as intended with the grasping hook moving freely, when pressing the release button.The grasping hook was straightened as reported.Based on the information provided and the investigation findings it cannot be determined, why the blue button got stuck, and why the filter would not release in the first place, but most likely the grasping hook, was straightened when attempting to resheath the tilted filter and the filter "would not resheath".Also, it cannot be determined, why the device "made an audile pop noise and the filter deployed", but it is noted that the filter was left in situ and is planned to be removed in a few months.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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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