Preventing Serious Injuries from Hemostasis Devices
FDA Patient Safety News: Show #3, April 2002

Since 1996, FDA has received over three thousand reports of adverse events associated with the use of vascular hemostasis devices. These are also known as arteriotomy closure devices, and they're used to seal off the femoral artery puncture site in patients undergoing cardiac catheterization procedures. They provide an alternative to manual compression, which is the traditional method of closing the puncture site.

Reported complications with these devices include hematoma, retroperitoneal bleeding, pseudoaneurysm, and infection. In fact, surgical intervention was needed to repair the femoral artery in almost a third of the reports we received. And some of the reported complications have even resulted in patient deaths.

In one report, continued oozing was observed at the insertion site after a cardiac catheterization procedure, and the patient was diagnosed with retroperitoneal bleeding. A large hematoma caused urethral obstruction, which led to kidney damage and eventually the patient had to undergo hemodialysis. In another case, a patient was discharged following closure with a vascular hemostasis device, only to return days later with bleeding from the groin. This patient then required surgery to repair a ruptured pseudoaneurysm.

In 1999, FDA issued a notification to practitioners about how to minimize these kinds of complications. Because we're continuing to receive many complication reports, we want to re-emphasize those recommendations.

In general, the FDA notification stressed the importance of recognizing that there are several different types of hemostasis devices approved by FDA, so manufacturers' instructions and recommendations for individual devices will vary. It's important to carefully follow the manufacturer's warnings, precautions and instructions on how to select patients and use the particular device you've chosen.

Users should also be sure to complete the training recommended by the specific device manufacturer, since training on how to properly use these devices also varies from device to device.

In addition, the notification listed several specific recommendations.

First, do not use vascular hemostasis devices to treat patients with suspected double wall vessel punctures. Punctures of the posterior wall are not closed with these devices.

Second, when treating patients with bleeding disorders or those medicated with platelet glycoprotein iib/iiia receptor inhibitors, carefully weigh the benefits of using a vascular hemostasis device against the risk of bleeding at the puncture site.

Third, pay special attention to any post-procedure patient-management instructions or ambulation recommendations for the specific device being used.

And most importantly, carefully monitor the groin puncture site to minimize the chance of complications. Instruct patients to contact their care provider if they experience any signs or symptoms of late bleeding like hematoma or swelling.

Of course it's important to recognize that complications can also occur when manual compression is used to close the puncture site. An important question is whether these complications occur more frequently with one method of closure than with another. FDA hopes to help answer that question with some research over the next year or two.

Additional Information:

Article: Complications Related to the Use of Vascular Hemostasis Devices (International Journal of Trauma Nursing) (see article below).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062281


FDA Patient Safety News is available at www.fda.gov/psn