Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.
Brian C CaseSant KumarGiorgio A MedrandaCharan YerasiBrian J ForrestalLowell F SatlerItsik Ben-DorHayder HashimNelson L BernardoToby RogersRon WaksmanPublished in: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2021)
Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.