Device-Related Problems and Patient Complications Associated With Endoscopic Ultrasound Needles: A Ten-Year Analysis From the MAUDE Database

Introduction: Endoscopic ultrasound (EUS) needles have been in use for many years and are known for their efficacy in diagnosing and managing a variety of conditions. Their safety and efficacy have been well-documented in the literature, however, there is a scarcity of information related specifically to device-related issues and patient-related complications. This study aims to investigate the patient-related adverse events and device failures associated with EUS-FNA and EUS-FNB needles using the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The reports from 2013 until 2023 were gathered using relevant search terms related to brand names of EUS needles in the MAUDE Database. 1610 reports comprising 1091 adverse events were identified from and duplicates were removed. Device and patient problems were organized by categories and counted. Results: A total of 981 unique problems from 1610 reports and 1091 adverse events were confirmed from the MAUDE database associated with EUS needles (Table 1). The highest number of events was reported in the year 2021 and 2017 (n=124, 12.64%). Device-related problems accounted for all the reported issues, and the leading issues were material integrity problem (n=404; 41.18%), multiple issues (n=248; 25.28%) and material activation or separation issue (n=157; 16.00%). Multiple device-related issues were reported in 25.28% (n=248) cases. Patient-related problems were primarily reported as no clinical signs, symptoms, or conditions (n=780; 79.51%). The remaining patient problems included foreign body in patient (n=94, 9.58%), bleeding (n=22, 2.24%), pain (n=16, 1.63%), injury (n=12, 1.22%), infection (n=6, 0.61%), and death (n=3, 0.31%). The three patient deaths were reported in 2015-2019, no deaths were detected in the four most recent years. Conclusion: The use of EUS needles are generally safe and effective. Despite the reported device-related problems, patient complications were typically minor and infrequently resulted in death. The dominant device-related issues were material integrity problem or activation and separation issue. Table 1. - Patient-Related Adverse Events and Device Failures Associated With EUS-FNA Panel 1A: Reported patient problems from U.S. FDA MAUDE Database Patient Problem Count No Clinical Signs, Symptoms or Conditions 780 Foreign Body In Patient 94 Other/Insufficient Information 46 Bleeding 22 Pain 16 Injury 12 Infection 6 Death 3 Multiple 2 Grand Total 981 Panel 1B: Reported device problems from U.S. FDA MAUDE Database Device Problem Count Material Integrity Problem 404 Multiple Issues 248 Material Activation or Separation Issue 157 Off-Label Use 63 Device Operates Differently Than Expected 51 Adverse Event Without Identified Device or Use Problem 39 Other 7 Contamination 7 Product Quality Problem 5 Grand Total 981