Device evaluated by mfr: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was functionally tested and the balloon was able to deflate without any issues.Inspection of the remainder of the device presented no other damage or irregularities.
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It was reported that slow deflation occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 5.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use.During the procedure, the device deflated very slow after 180 seconds of expansion at 8atm.The procedure was completed with this device.There were no patient complications.
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