Device is a combination product.A 16 x 3.50mm promus elite stent delivery system was returned for analysis.A visual (via scope) examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured by snap gauge and was within max crimped stent profile measurement.A visual examination (via scope) of the balloon sections found no issues.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual (via scope) and tactile examination of the hypotube found a hypotube break 23.6cm distal to distal end of strain relief (proximal of shaft markers), slight bending of the hypotube was noted on both sides of break.Multiple hypotube kinks were also noted along length of hypotube.A visual (via scope) and tactile examination of the shaft polymer extrusion found no issues.A visual (via scope) examination of the tip found no issues with the tip.The device was loaded onto and tracked over a 0.014 inch guidewire without issue.
|