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JAMA. 1999;282:1995.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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:

• Carefully follow the manufacturer's warnings, precautions, and instructions.
  
• Do not use these devices to treat patients with suspected punctures of the posterior wall, because these devices will not close the punctures.
  
• Weigh the risk of bleeding at the puncture site against the benefits of using a closure device when treating patients with bleeding disorders or patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors.
  
• Monitor the groin puncture site to minimize the occurrence of complications.
  
• Observe postprocedural . . . [Full Text of this Article]