MUSTANG?

Description of Event or Problem

It was reported that balloon rupture and separation occurred, requiring additional intervention. The target lesion was located in an arteriovenous shunt. A 8.0 x 80, 75cm Mustang balloon catheter was advanced from the arterial side of the AV shunt through the loop to the venous side and across a previously implanted covered stent. During inflation at 18 atmospheres with a rated burst pressure of 20 atmospheres, the balloon ruptured and separated into two pieces. The balloon became entrapped by the covered stent and could not be withdrawn. Surgical intervention was performed to remove the retained balloon fragments. As a result of the event, the patients arteriovenous shunt could no longer be used for routine dialysis, and alternative dialysis access was required. No additional patient complications were reported as a result of this event.