Complications associated with use of the Wolverine cutting balloon: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.

OBJECTIVES

The Wolverine cutting balloon (CB) (Boston Scientific) is a specialized balloon catheter with microsurgical blades that is used for balloon-resistant lesions. The Manufacturer and User Facility Device Experience (MAUDE) database serves as a repository for reports of medical device complications. The aim of this study was to analyze complications associated with CB use during percutaneous coronary intervention in real-world contemporary practice.

METHODS

The MAUDE database was searched from January 1, 2020 through December 31, 2023 for reports of complications associated with CB use. Data from individual reports were extracted for analysis.

RESULTS

The final analysis included 2278 complications, of which 97.3% (n = 2216) were associated with device malfunction, 2.4% (n = 55) were associated with patient injury, and 0.3% (n = 7) were associated with patient death. The most common complication overall was balloon rupture (n = 1847), while the most common complication associated with patient injury or death was device entrapment (n = 33). The median number of inflations was significantly higher for complications associated with patient injury or death (3 [IQR 1-8]) compared with complications associated with device malfunction (1[IQR 1-2]) (P = .0035). The median maximum inflation pressure was significantly higher for complications associated with patient injury or death (12 [IQR 11-15] atm) compared with complications associated with device malfunction (8 [IQR 6-10] atm) (P = .0001).

CONCLUSIONS

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.