Visual analysis was performed on the returned device.The reported failure to advance was unable to be confirmed due to the condition of the returned unit.Additionally, the exit notch was noted to be torn.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 determined that the reported failure to advance was likely related to circumstances of the procedure.It is likely that anatomical conditions prevented the ability to cross and during the failure to cross, the interaction of the device with the guide wire resulted in the noted torn exit notch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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