Since 1996, FDA has received reports of adverse events, including deaths, concerning closure devices. 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.
Review of the literature does show that the types of complications associated with manual compression and vascular hemostasis devices are similar. After analyzing the specific circumstances that led to the adverse events reported for vascular hemostasis devices, we believe that the following recommendations may be helpful in minimizing adverse events relating to the use of these devices. Recommendations Manufacturers' instructions and recommendations may vary for individual vascular hemostasis devices. In general, to avoid complications when using vascular hemostasis devices, we recommend that you carefully follow the device manufacturer's warnings, precautions, and instructions regarding patient selection and device use. Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices.