(b)(4).Visual inspection was performed on the returned device.The reported collapsed tip was not confirmed.The investigation was unable to determine a conclusive cause for the noted hypotube separation.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 similar incidents from this lot.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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