(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported folded (winged balloon) and deflation issue could not be 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 of the reported lot did not indicate a lot specific quality issue.It was reported that the device was used to treat a right renal artery.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: the nc trek rx coronary dilatation catheter is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass, graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
|