The device was not returned for evaluation.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional emboshield nav6 device referenced in event and concomitant medical products is filed under separate medwatch report number.
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