Device malfunctions with use of EUS–guided fine-needle biopsy devices: Analysis of the MAUDE database

Abstract

ABSTRACT Background The safety of endoscopic ultrasound–guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]). The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.