Description of event according to initial reporter: during a filter placement procedure which the cook celect platinum navalign jugular vena cava filter set, (b)(4), was used.While trying to deploy the physician pushed the button and the filter did not deploy.After pushing the button approximately 5-8 times the filter deployed.Filter deployed in the patient where intended and the procedure was completed with no further complications.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on description of event and the returned device.It was reported that the filter would not release at first, but released after repeatedly pressing the release button without any harm to the patient.Only the jugular introducer with biological matter was returned.The red safety button was pressed.The spring mechanism worked as intended and the grasping hook moved freely, when pressing the blue release button.The dimensions of the grasping hook were according to specifications.Based on these finding the exact reason for the difficulties encountered, when attempting to release the filter cannot be determined, but excessive tension may have caused them.According to the instructions for use excessive tension should not be applied to the device during attempted filter release, as this may prevent the filter from releasing.There are adequate controls in place to ensure the device was manufactured to specifications the device history record was reviewed with no evidence to suggest that this device was not manufactured according 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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