Almasri Hussam, Karna Rahul, Sidhu Guneet, Khataniar Himsikhar, Bassett John, Bilal Mohammad
University of North Dakota School of Medicine and Human Science, Fargo, ND, USA.
University of Minnesota, Minneapolis, MN, USA.
Dig Dis Sci. 2025 Jul 24. doi: 10.1007/s10620-025-09224-3.
Sphincterotomes are widely used during endoscopic retrograde cholangiopancreatography (ERCP) for duct cannulation and sphincterotomy. ERCP can be associated with various adverse events (AEs); however, those associated with sphincterotome device problems are not well known. We aim to analyze device problems and patient-related AEs associated with sphincterotomes using the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
After a comprehensive search, we analyzed the post-marketing surveillance data for sphincterotomes from the FDA's MAUDE database to report device-related deaths, injuries, and modes of failure from January 2014 to September 2024. Data related to manufacturers, device problems, and patient outcomes was collected, and descriptive statistics were performed to summarize findings. Report trends over time analysis was also performed.
3909 reports of events related to sphincterotome use were found through September 2024. Total reports by major manufacturers include Boston Scientific (Natick, MA, USA): 44% (1721/3909), Cook Endoscopy (Winston Salem, NC, USA): 22.7% (887/3909), and Olympus (Center Valley, PA, USA): 33.3% 1301/3909. The most common event was malfunction in 94.7% (3701/3909) followed by injury in 5.1% (200/3909) and death in 0.2% (8/3909). The most common device problem was break in 59.8% (2339/3909). A total of 248 patient-related AEs were identified with the most common being foreign body in patients (n = 61, 24.6%) followed by hemorrhage (n = 55, 22.2%), perforation (n = 44, 16.5%), and pancreatitis (n = 40, 16.1%). There was a positive trend of reports years between 2014 and 2021 with p < 0.001.
Based on post-marketing surveillance data from the FDA's MAUDE database, our analysis of sphincterotome reports suggests that mechanical failure, particularly device breakage is the most prevalent device problem, and foreign body was the most common patient-related AE. While reported adverse events appear to increase over time, this may reflect increased sphincterotome utilization/procedure volume or reporting vigilance rather than true increases in device-related complications.
在内镜逆行胰胆管造影术（ERCP）期间，括约肌切开刀被广泛用于胆管插管和括约肌切开术。ERCP可能与各种不良事件（AE）相关；然而，与括约肌切开刀设备问题相关的不良事件尚鲜为人知。我们旨在使用美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（MAUDE）数据库分析与括约肌切开刀相关的设备问题和患者相关不良事件。
经过全面检索，我们分析了FDA的MAUDE数据库中括约肌切开刀的上市后监测数据，以报告2014年1月至2024年9月期间与设备相关的死亡、伤害和故障模式。收集了与制造商、设备问题和患者结局相关的数据，并进行描述性统计以总结研究结果。还进行了随时间变化的报告趋势分析。
截至2024年9月，共发现3909份与使用括约肌切开刀相关的事件报告。主要制造商的报告总数包括波士顿科学公司（美国马萨诸塞州纳蒂克）：44%（1721/3909），库克内镜公司（美国北卡罗来纳州温斯顿塞勒姆）：22.7%（887/3909），以及奥林巴斯公司（美国宾夕法尼亚州中心谷）：33.3%（1301/3909）。最常见的事件是故障，占94.7%（3701/3909），其次是伤害，占5.1%（200/3909），死亡占0.2%（8/3909）。最常见的设备问题是断裂，占59.8%（2339/3909）。共识别出248例患者相关不良事件，最常见的是患者体内异物（n = 61，24.6%），其次是出血（n = 55，22.2%）、穿孔（n = 44，16.5%）和胰腺炎（n = 40，16.1%）。2014年至2021年期间报告数量呈上升趋势，p < 0.001。
基于FDA的MAUDE数据库的上市后监测数据，我们对括约肌切开刀报告的分析表明，机械故障，尤其是设备断裂是最普遍的设备问题，而异物是最常见的患者相关不良事件。虽然报告的不良事件似乎随时间增加，但这可能反映了括约肌切开刀使用量/手术量的增加或报告警惕性的提高，而非设备相关并发症的真正增加。
