Visual, dimensional, and functional analysis was performed on the returned device.The reported difficulty advancing and difficulty removing was not 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 similar complaints reported from this lot.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the difficulty advancing was the result of challenging anatomical conditions at the location of the peroneal artery.Additionally, the difficulty removing may be the result of the atherectomy device being advanced too close to the filter causing the tip of the atherectomy catheter to become stuck with the proximal end of the filtration element resulting in difficulty removing.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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