Volcano—s5 and CORE Intravascular Ultrasound Imaging Systems: Aortic Pressure Offset Error May Lead to Inaccurately Calculated FFR or iFR Value

July 1, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a June 22, 2015, Urgent Medical Device Field Corrective Action letter submitted by an ECRI Institute member hospital, Volcano states that the following specific workflow scenarios may cause the Aortic pressure (Pa) offset used in the fractional flow reserve measurement (FFR)/instantaneous wave-free ratio (iFR) modalities to be lost or reset to 0 mmHg, leading to an inaccurately calculated FFR or iFR value:

(1) The user goes from FFR/iFR...

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