Potential Adverse Events; Reporting Adverse Events - Abbott Ultiri 1015082 Operation Manual

Potential Adverse Events

Potential complications which may be encountered during all catheterization
procedures include, but are not limited to:
•
Angina
•
Arrhythmia
• Bleeding
• Coronary vascular injury
•
Death
•
Drug reactions to vasodilators (e.g., Adenosine
to induce hyperemia during FFR determination such as bronchospasm,
dyspnea, bradycardia, coronary artery spasm
•
Hypotension
•
Infection
•
Ischemia
• Potential allergic reactions to drugs administered for the procedure
• Stenosis

Reporting Adverse Events

The user and / or patient should report any serious incident that has occurred in
relation to the Ultiri™ Measurement System to the manufacturer and the
competent authority of the Member State in which the user and / or patient is
established.
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Reporting Adverse Events
or nitroglycerine) used
‡
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