Medical device surveillance: gender differences in pulmonary artery rupture after pulmonary artery catheterization.

Background: Pulmonary artery (PA) rupture is a rare but often fatal complication of PA catheterization.

Methods: An analysis was performed of all the case reports of PA rupture after PA catheterization that were submitted to the Food and Drug Administration's Medical Device Reporting (MDR) system between the years 1991 and 2001. The MDR system is a national passive surveillance system that includes adverse event reports from such sources as manufacturers and healthcare professionals.