The FDA is informing practitioners about adverse events involving the use of vascular hemostasis devices following percutaneous femoral arterial punctures in patients undergoing diagnosis and treatment for cardiovascular disease. Complications include hematoma, retroperitoneal bleed, pseudoaneurysm, late bleeding, and, infrequently, death. Similar complications occur with manual compression.
After analyzing the specific circumstances that led to adverse events reported since 1996, the FDA believes the following recommendations may be helpful in minimizing injuries involving closure devices:
Henney JE. Complications Related to Vascular Hemostasis Devices. JAMA. 1999;282(21):1995. doi:10.1001/jama.282.21.1995