Visual and dimensional analysis was performed on the returned device.The reported difficulty to insert was unable to be confirmed due to the condition of the returned delivery catheter.The damage/separation to the delivery catheter was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing separation of the shaft material and damage to the delivery catheter pod preventing the filtration element from being able to load properly; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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