Model Number G34309 |
Device Problems
Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Investigation is still in progress.Pma/510(k): k171712.
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Event Description
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Description of event according to initial reporter: the physician expressed that he has had difficultly with the ivc filter releasing once the red safety button is released in approximately the last five cases (lot # e3857935 registered as (b)(4)).He has to rotate the delivery system for the filter to finally release once the blue button is pushed.All have eventually released but some are tilted in the ivc that are going to make retrieval challenging.There has been reached out to the department manager to see if they can send the lot numbers of the remaining filters (registered as (b)(4))." patient outcome: some part of the device remained inside the body of the patient.Device is meant to be left in place in the ivc until no longer medically needed and then will be retrieved with a ivc filter retrieval device.No adverse effects was reported on the patient due to this occurrence.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Investigation is still in progress.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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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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