Device returned to manufacturer: the packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The device was received in a carton for batch 26757951.There was no pouch in the carton.The device was from batch 26757951.The device inspection found there were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported mislabeling as there was no pouch returned with the device.
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