Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the filter would not open, and a retrieval kit then had to be opened to remove the filter.Another device was then used to place a filter successfully.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.According to the instruction for use potential adverse events that may occur include, but are not limited to, the following: failure of filter expansion/incomplete expansion.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information it is unknown what caused the filter not to open properly when it was released.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding, maybe if the filter is deployed in a thrombus, or if the filter legs are caught in a clot but this is purely speculations.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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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