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 incidents from this lot.The investigation determined the reported difficulty to advance appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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