Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 83cm distal from the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 9mm long starting 1mm proximally from the proximal marker band.The device was functionally tested with a.014 inch.The guidewire was unable to advance past the proximal marker band due to a kink on the inner shaft.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a longitudinal tear on the balloon and was unable to fully insert a guidewire.
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