The device was not returned for analysis.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 other complaints reported from this lot.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 damage to the delivery catheter pod and causing the filtration element to separate from the barewire preventing the ability to load; 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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It was reported that during preparation of the emboshield nav6 embolic protection system (eps) the filter met difficulty to be pulled into the delivery catheter (dc) pod using the torque.During this maneuver, the filter compressed and snapped off from the delivery system.There was no bunching or wrinkling.Another emboshield nav6 was used to complete the procedure.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.No additional information was provided.
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