LAUSR

• Suture-based vascular closure devices are highly effective but can fail because of operator, patient, and procedure factors. • This report from the FDA MAUDE database of device failures included half where such failure led to bleeding or vascular injury requiring surgical or endovascular repair, and death in two patients. • This real-world data is limited by self-reporting and an unclear volume of procedures but may help operators understand the failure modes and potential consequences.