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. The Nationwide Inpatient Sample (NIS), a massive, nationally representative database maintained by the Agency for Healthcare Research and Quality, was examined to study patterns of PA catheter use.


RESULTS
A total of 71 PA rupture cases were identified from the MDR data. The most likely outcome following PA rupture was death. These PA ruptures were associated with 47 deaths and 24 injuries. The range of reported ages of the cases was between 40 and 91 years, with a mean age of 74 years. Of the 71 PA rupture cases, 52 were in women and 10 were in men, with gender not reported in 9 of the cases. There were significantly more cases in women than expected (Mantel-Haenszel common odds ratio estimate = 5.84, 95% confidence interval = 2.97 - 11.46, p < 0.001).


CONCLUSIONS
These data suggest that women may be at significantly greater risk of PA rupture after PA catheterization than men. Clinicians must be aware of the potential for this complication of PA catheterization.
Kaczmarek
Ronald G
RG
Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, USA. rxk@cdrh.fda.gov
Liu
Chih-Hsin K
CH
Gross
Thomas P
TP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002407:Catheterization, Swan-Ganz / Q000009:adverse effects* / Q000401:mortality; D016208:Databases, Factual; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D019221:Mandatory Reporting; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011651:Pulmonary Artery / Q000293:injuries*; D012307:Risk Factors; D012421:Rupture / Q000453:epidemiology* / Q000209:etiology; D012737:Sex Factors; D014481:United States / Q000453:epidemiology