The device was returned for analysis.Visual, tactile, and microscopic analysis were performed on the device.A visual examination of the balloon identified no damages.Multiple hypotube kinks were noted along the shaft of the device, a midshaft kink was 2.5cm from the port exchange and a break was identified, 27.5cm distal to the distal end of the strain relief.No kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.Multiple hypotube kinks were noted along the shaft of the device, a midshaft kink was 2.5cm from the port exchange and a break was identified, 27.5cm distal to the distal end of the strain relief.
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