Pulmonary artery rupture: serious complication associated with pulmonary artery catheters.
An analysis of the Manufacturer and User Facility Device Experience database of the Food and Drug Administration was conducted to identify adverse event reports associated with pulmonary artery catheter use between 1993 and 1999. Of 714 adverse event reports, there were 48 deaths of which 42 (88%) were related to pulmonary artery rupture. A further analysis of risk factors was conducted and found "postmenopausal female" was a most significant finding. Further study is recommended to establish a causal relationship.
Liu
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Food and Drug Administration, Center for Devices and Radiologic Health, Office of Surveillance and Biometrics, 1350 Piccard Dr, HFZ 520, Rockville, MD 20850, USA.
Webb
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CC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002407:Catheterization, Swan-Ganz / Q000009:adverse effects* / Q000451:nursing / Q000706:statistics & numerical data*; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017698:Postmenopause; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011651:Pulmonary Artery / Q000293:injuries*; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data