FDAnews Device Daily Bulletin

STUDY POINTS TO RISK OF ADVERSE EVENTS FROM USE OF HEMOSTASIS DEVICES

July 27, 2006
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A study in the Journal of Invasive Cardiology published July 26 found an increased risk of serious adverse events following cardiac catheterization with certain devices used in hemostasis, a process to stop bleeding.

The study was initiated following reports to the FDA of serious injuries and deaths associated with the use of hemostasis devices, the article noted.

One particular device, VasoSeal, which is manufactured by Datascope, "appears to pose a greater risk for serious local vascular complications following cardiac catheterization than either manual compression controls or other hemostasis devices," and "women have almost twice the risk of men for most local complications," the article noted.

Data was culled from 59 institutions and 13,878 cardiac catheterizations performed during the last quarter of 2003, researchers said. Serious adverse events were reported in 3.37 percent of patients, and the most common event was bleeding with a blood clot, or hematoma (2 percent).

The article can be viewed at www.invasivecardiology.com/jic/displayArticle.cfm?articleID=article4937 (http://www.invasivecardiology.com/jic/displayArticle.cfm?articleID=article4937).