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

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

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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 patients
  condition. He continued to deteriorate,
  experienced cardiac arrest, and died.
• The patients reported cause of death was
  exsanguination (massive loss of blood) as a
  result of retroperitoneal bleeding (bleeding into
  the back side of the abdomen).

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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

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FDA Actions (Continued)

• Review and analysis of reported adverse events
• Review of scientific and medical literature
• Publish articles in peer-reviewed clinical
  nursing journals

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FDA Actions (Continued)

• Convene FDA workgroup to evaluate
• the etiology of the reported complications
• Issue safety alert notification to healthcare
  practitioners

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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.

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(No Transcript)
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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

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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.