Lee Aaron, Jung Dorothy, Ahmed Mohammad, Norton Jonathan, Kaleta Francois, Muallem Samer, Patel Maulin, Mathur Moses, Kozak Mark, Gilchrist Ian C, Zack Chad J
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania. Email:
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
J Invasive Cardiol. 2025 May;37(5). doi: 10.25270/jic/24.00300.
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.
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.
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).
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.
金刚狼切割球囊（CB）（波士顿科学公司）是一种带有显微手术刀片的专用球囊导管，用于治疗对球囊扩张有抵抗的病变。制造商和用户设施设备经验（MAUDE）数据库是医疗器械并发症报告的存储库。本研究的目的是分析在现实世界的当代实践中，经皮冠状动脉介入治疗期间使用CB相关的并发症。
检索MAUDE数据库2020年1月1日至2023年12月31日期间与使用CB相关的并发症报告。提取各报告中的数据进行分析。
最终分析包括2278例并发症，其中97.3%（n = 2216）与设备故障相关，2.4%（n = 55）与患者损伤相关，0.3%（n = 7）与患者死亡相关。总体上最常见的并发症是球囊破裂（n = 1847），而与患者损伤或死亡相关的最常见并发症是设备嵌顿（n = 33）。与设备故障相关的并发症相比，与患者损伤或死亡相关的并发症的充气中位数显著更高（3[四分位间距1 - 8]）（P = 0.0035）。与设备故障相关的并发症相比，与患者损伤或死亡相关的并发症的最大充气压力中位数显著更高（12[四分位间距11 - 15]大气压）（P = 0.0001）。
总体而言，报告的并发症中有2.7%与患者损伤或死亡相关。总体上最常见的并发症是球囊破裂。在与患者损伤或死亡相关的报告中，设备嵌顿是最常见的并发症。更高的充气压力和更多的充气次数可能与不良结局相关。
