Description of event according to initial reporter: "the filter was unable to release from the introducer hook by pressing the deployment blue button.After pressing the blue button for at least 4-6 times, finally the filter was release from the introducer hook." patient outcome: patient is well.The deployment button jammed, but finally able to deploy.
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Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the filter did not release, when the release button was pressed, but finally it release in good position.Only the jugular introducer with protection sheath was returned.The introducer was curved and kinked 60mm, 354mm, and 356mm from distal end, likely because it was wrapped and placed in a small plastic bag for return.The red safety button was pressed down, ie the system was unlocked.The grasping hook and the hook wire stuck inside the introducer and could not be moved, when pressing the release button.It still stuck after soaked in water, why the handle was opened, but no nonconformances were found inside the handle.Consequently, the grasping hook was cut from the hook wire and pushed through the introducer, but a lot of biological matter was pushed through, too.The hook was cleaned and an investigation revealed no non-conformances.After the hook was cut, the hook wire moved freely and worked as intended, when the blue release mechanism in the handle was pressed.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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