Visual and functional inspections were performed on the returned device.The inflation issue was confirmed.Additionally fluid was observed coming out of the noted tear in the shaft.It may be possible that the shaft of the armada 14 was inadvertently pulled during removal of the unit from the coil dispenser or other mishandling thus causing it to kink and tear.However, this could not be confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation was unable to determine a conclusive cause for the leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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