About Complications Related to the Use of Vascular Hemostasis Devices

Vascular Hemostasis Devices provide an alternative to manual compression in achieving hemostasis following percutaneous femoral arterial punctures in patients undergoing diagnosis and treatment for cardiovascular disease. Complications reported related to these devices include hematoma, retroperitoneal bleed, pseudoaneurysm, late bleeding, and infrequently, death.

In one case, a patient, who had previously been treated with a vascular hemostasis device, suffered an acute myocardial infarction. During the ensuing catheterization, the hemostasis device was dislodged, necessitating surgical intervention. In another case, following closure with a vascular hemostasis device, the patient was discharged only to return days later with bleeding from the groin. This patient then required surgery to repair a ruptured pseudoaneurysm.

Complications can also occur when manual compression is used to achieve hemostasis.

Manufacturers’ instructions and recommendations may vary for individual vascular hemostasis devices. To avoid complications when using vascular hemostasis devices, it is recommended the device manufacturer’s warnings, precautions, and instructions regarding patient selection and device use be carefully followed.

For more details, please visit : 
http://www.fda.gov/cdrh/safety/vashemo.html