Visual analysis was performed on the returned device.The reported difficulty to insert was unable to be confirmed due to the condition of the returned device.The reported dc pod damage 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 identified no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the delivery catheter pod preventing the filtration element from being able to load properly; however, this could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.
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