Visual and functional analysis was performed on the returned device which identified that the shaft was separated 7.5cm proximal to the distal end of the strain relief.The reported deployment issue was confirmed.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.The investigation determined that the deployment issue was related to circumstances of the procedure.The separation of the proximal outer member within the handle indicates that the distal shaft/sheath of the rx acculink was restricted preventing movement of the sheath during retraction of the slider.Further attempts to retract the slider with the distal sheath restricted likely caused the proximal outer member separation preventing transmission to the distal sheath and deployment failure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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