Kalpana Gopalkrishnan, 1, Patrick Chang, MD1, Sarah Wang, MD, MPH2, Linda Huang, MD2, Supisara Tintara, MD3, William Minteer, MD2, Ara B. Sahakian, MD2, James Buxbaum, MD, MS2, Jennifer Phan, MD2 1University of Southern California, Los Angeles, CA; 2Keck School of Medicine of USC, Los Angeles, CA; 3Keck School of Medicine, University of Southern California, Los Angeles, CA
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.
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.
Discussion: 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 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
Table 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
Disclosures:
Kalpana Gopalkrishnan indicated no relevant financial relationships.
Patrick Chang indicated no relevant financial relationships.
Sarah Wang indicated no relevant financial relationships.
Linda Huang indicated no relevant financial relationships.
Supisara Tintara indicated no relevant financial relationships.
William Minteer indicated no relevant financial relationships.
Ara Sahakian indicated no relevant financial relationships.
James Buxbaum: Boston Scientific – Consultant. Olympus – Consultant.
Jennifer Phan: Boston Scientific – Consultant. Cook Medical – Consultant. Olympus – Consultant.
Kalpana Gopalkrishnan, 1, Patrick Chang, MD1, Sarah Wang, MD, MPH2, Linda Huang, MD2, Supisara Tintara, MD3, William Minteer, MD2, Ara B. Sahakian, MD2, James Buxbaum, MD, MS2, Jennifer Phan, MD2. P0553 - Device-Related Problems and Patient Complications Associated With Endoscopic Ultrasound Needles: A Ten-Year Analysis From the MAUDE Database, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
