(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual inspection and functional inspection was performed on the returned device.The difficulties could not be replicated due to the condition of the returned device.It was noted that the outer member was separated at two locations (outer member was separated 1.3cm proximal to the proximal end of distal outer sheath and the inner braiding and the outer member was separated 2mm distal to the proximal end of the rack).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 of the reported lot revealed no other incidents.The investigation determined that the reported difficulties and subsequent treatment were likely due to operational circumstances of the procedure.Kinks were noted on the distal sheath which suggest that the sheath was likely bent/restricted in the anatomy and caused restriction between the shaft lumens, resulting in difficulty rotating the thumbwheel and deployment failure due to the outer member separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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