"the device did not deploy initially after unsheathing the filter.Physician pressed the red button and then swiftly the blue button.Device deployed after continuously hooking and pushing the blue button and the device fell off into the patient.Once it was deployed, nothing further had to be done and the patient is fine." 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.
|
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Summary of investigational findings: the physician pressed the red safety button and then swiftly the blue button.The filter was first deployed after continuously pushing the blue release button.No adverse effects on the patient was reported due to this occurrence.No product was returned for evaluation, however, there are adequate controls in place to ensure the device was 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.Ifu states that the user must keep slight back tension on the introducer, when the release button is pushed, however, tt is possible that not enough slight back tension was executed.On the other hand, ifu do also warns against excessive tension during deployment, which may prevent the filter from releasing, and this could also be a possible cause for the reported event.Lastly, ifu states that the release button must be pushed completely to release of the filter, but it is possible that the user did not push the button completely and therefore felt difficulty in releasing the filter.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.
|