It was reported that during preparation of the emboshield nav 6 embolic protection system (eps), when loading the filtration element into the delivery catheter (dc) pod with the torque device, the tip of the bare wire was noted to be unraveling thus prevented the filtration element from being loaded into the dc pod.Bunching and wrinkling was observed on the dc pod during loading but was not noted prior to loading.The eps device was not used.A new emboshield nav6 eps was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Visual, dimensional, and functional analysis was performed on the returned device.The reported damage to the barewire and dc pod was confirmed.The reported difficult to insert was unable to be confirmed due to the condition of the returned delivery catheter and barewire; however, functional testing with returned filter and proxy delivery catheter and barewire were successful.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 difficulty.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing the noted damage to the delivery catheter pod, damage to the barewire tip and difficulty loading the filtration element; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.
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