B3: date of event: use the first day of the month of the aware date as the event date, as it was not provided.A synergy xd mr us 2.25 x 38mm stent delivery system (sds), catheter was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.No issues were identified with the hypotube shaft.The inner polymer extrusion was stretched, 6.4 cm from tip of the device.There was no sign of damage, stretching or lifting of the stent struts.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.There was a kink noted in the lasercut section, 2.5 cm from the port exchange.The device was attached to an encore inflation unit and an attempt to inflate the balloon, however, a leak was noted where the kink was in the lasercut section.No other device issues were identified during returned product analysis.
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