Typology, Severity, and Outcomes of Adverse Events Related to Angiographic Equipment—A Ten-Year Analysis of the FDA MAUDE Database

Abstract

Purpose: Angiographic equipment is a key component of healthcare infrastructure, used for endovascular procedures throughout the body. The literature on adverse events related to this technology is limited. The purpose of this study was to analyze adverse events related to angiographic devices from the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. Methods: MAUDE data on angiographic imaging equipment from July 2011 to July 2021 were extracted. Qualitative content analysis was performed, a typology of adverse events was derived, and this was used to classify the data. Outcomes were assessed using the Healthcare Performance Improvement (HPI) and Society of Interventional Radiology (SIR) adverse event classifications. Results: There were 651 adverse events reported. Most were near misses (67%), followed by precursor safety events (20.5%), serious safety events (11.2%), and unclassifiable (1.2%). Events impacted patients (42.1%), staff (3.2%), both (1.2%), or neither (53.5%). The most common events associated with patient harm were intra-procedure system shut down, foot pedal malfunction, table movement malfunction, image quality deterioration, patient falls, and fluid damage to system. Overall, 34 (5.2%) events were associated with patient death; 18 during the procedure and 5 during patient transport to another angiographic suite/hospital due to critical failure of equipment. Conclusion: Adverse events related to angiographic equipment are rare; however, serious adverse events and deaths have been reported. This study has defined a typology of the most common adverse events associated with patient and staff harm. Increased understanding of these failures may lead to improved product design, user training, and departmental contingency planning.

Adverse Events Self-Reporting in Radiology:A New Avenue for Excellence

“…However, and sadly, 34/651 (5.2%) events were associated with or resulted in patient death. 3 This study is of major interest as it places a specific highlight on underreported events that may have a terrible outcome.…”

“…In this issue of the Canadian Association of Radiologists Journal, Healy et al 3 have analyzed adverse events related to angiographic devices that occurred during vascular interventions performed by cardiologists, vascular and interventional radiologists, interventional neuroradiologists and vascular surgeons. These adverse events were extracted in November 2021 from the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database, which is a publicly searchable surveillance database of adverse events related to medical devices.…”

“…Healy et al 3 have to be congratulated for their article because they made a detailed description of adverse events due to angiographic equipment malfunction that can occur in vascular interventional radiology. Although their work is restricted to the analysis of angiographic equipment malfunction because of the nature of the MAUDE database, it alerts all interventional radiologists on the need to report adverse events and to develop more comprehensive databases in the field of interventional radiology.…”