Reportable based on device analysis completed on 29-feb-2024.It was reported that balloon leak occurred.The 70% stenosed target lesion was located in the mild tortuous and severely calcified vessel.During the procedure, after 8x90 venous wallstents were placed, a 18-6/5.8/75 xxl esophageal balloon catheter was advanced into bilateral bifurcation compression and another 18-6/5.8/75 xxl esophageal balloon advanced into the bilateral common iliac vein (civ) compression.Both balloons were placed just below the proximal part of the stents and the physician started the kissing balloon technique, but neither balloons would reach 5 atmospheres.A balloon leak was noted.The balloons were replaced, and the case was finished successfully.No complications were reported.However, returned device analysis revealed a balloon pinhole.
|