Health Canada — Medical Devices · Canada · 2018-05-18 · Type II
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Reported risk: Edwards Lifesciences has received a limited number of reports (11 reports since December 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. When present, this leak can be identified through normal monitoring of balloon pressure, and it causes the medical staff to continue adding inflation fluid to the balloon, typically about 2-5 ml every 10-15 minutes for up to 50 ml total, to maintain balloon pressure sufficient for adequate occlusion of the ascending aorta.
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