Bsc aware date: july 3, 2020.Device evaluated by mfr.: returned product consisted of a threader balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the guidewire lumen.The balloon was loosely folded.The shaft was buckled in numerous areas.There was a 1mm long buckle 5mm from the tip, a 3mm long buckle 13mm from the tip, a 1mm long buckle 34mm from the tip, a 1mm long buckle 41mm from the tip, a 1mm long buckle 43mm from tip, a 1mm long buckle 48mm from the tip, a 3mm long buckle 51mm from the tip, a 2mm long buckle 82mm from the tip, and a 9mm long buckle 91mm from the tip.The device was soaked in a water bath for an hour to loosen any blood and contrast in the device.The guidewire that was stuck in the device was removed.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the catheter was frozen on the wire.
|