Vascular Hemostasis Case Study Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

1. Vascular Hemostasis Case StudySonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

2. Vascular Hemostasis Devices • Vascular hemostasis devices are used percutaneously (applied through the skin) to seal off the femoral artery puncture site • Accessed for diagnostic and interventional cardiac procedures • An alternative to traditional manual compression by facilitating more rapid sealing of the arterial puncture site • Allows the patient to go home more quickly

3. Vascular Hemostasis Devices Case Description • A 39 year old man underwent a diagnostic cardiac catheterization. During the procedure the cardiologist used multiple needle sticks to locate the femoral artery. It is believed that the back wall of the femoral artery was punctured. • After the procedure, a hemostasis device was used to control bleeding at the femoral puncture site. Continuous oozing was noted from the site, the patient remained restless, and within 15 minutes of the procedure his blood pressure dropped significantly. Medications and medical interventions did not improve the patient’s condition. He continued to deteriorate, experienced cardiac arrest, and died. • The patient’s reported cause of death was exsanguination (massive loss of blood) as a result of retroperitoneal bleeding (bleeding into the back side of the abdomen).

4. FDA Actions • Review and analysis of reported adverse events • Review of scientific and medical literature • Convened FDA workgroup to evaluate to evaluate the etiology of the reported complications. • Published articles in peer-reviewed clinical nursing journals • Issue Safety Alert to healthcare practitioners • Poster Presentation at the 2001 FDA Science Forum • Developed epidemiological research studies to fully evaluate adverse events associated with various types of vascular hemostasis devices

5. FDA Actions (Continued) • Review and analysis of reported adverse events • Review of scientific and medical literature • Publish articles in peer-reviewed clinical nursing journals

6. FDA Actions (Continued) • Convene FDA workgroup to evaluate the etiology of the reported complications • Issue safety alert notification to healthcare practitioners

7. FDA Actions (Continued) • Poster Presentation at the 2001 FDA Science Forum on the results of a study of adverse event reports received between 1996-2000.

9. FDA Actions (Continued) • Develop epidemiological research projects to fully evaluate adverse events associated with various types of vascular hemostasis devices • Partner with the American College of Cardiology to utilize registry data to detect gender differences in frequency and severity of complications

10. Conclusions • Better understanding of the occurrence of adverse events associated with the use of vascular hemostasis devices following cardiac catheterization • Will assist health care practitioners to make better decisions regarding the use of these devices • Provides a basis for further research on the subject.