Complications Associated With Use of the Wolverine Cutting Balloon: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database

Overall, 2.7% of reported complications were associated with patient injury or death. The most common complication overall was balloon rupture. Device entrapment was the most common complication among reports associated with patient injury or death. Higher inflation pressures and greater number of inflations may be associated with adverse outcomes.