Abstract No. 12 A decade of angiographic device malfunction from the FDA MAUDE database

Abstract

Vascular and interventional radiology (VIR) relies on imaging equipment to perform procedures. This presents a critical need for understanding adverse events related to equipment such as angiographic devices, with implications for patient safety. We present a decade of adverse events involving angiographic devices from the U.S. Food and Drug Administration’s postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database.