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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Complications
Complications
The risks involved in vascular imaging include those associated with all
catheterization procedures. The following complications may occur as a
consequence of intravascular imaging and may necessitate additional medical
treatment including surgical intervention.
Warnings and Precautions
Warnings
Warnings (OCT)
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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
•
Abnormal heart rhythm or arrhythmias
•
Acute myocardial infarction
•
Allergic reaction to the contrast media or drug administered for the
procedure
•
Arterial dissection, injury, or perforation
•
Bleeding
•
Catheter access site reactions: sterile inflammation or granuloma
•
Coronary artery spasm
•
Death
•
Embolism
•
Myocardial ischemia
•
Renal insufficiency or failure from contrast media use
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Repeat revascularization
•
Thrombus formation, abrupt closure, or total occlusion
•
Tissue necrosis
•
Unstable angina
•
Hypotension
•
Prior to use, please review the installed software User Manual and the
Instructions for Use supplied with the OPTIS™ Integrated Next,
Dragonfly™ Imaging Catheter, Wi-Box™ AO Transmitter, and
PressureWire™ Guidewire for more information on warnings, limitations,
cautions, and setup instructions.
•
Leave the guide wire engaged with the Dragonfly Imaging Catheter at all
times during use. Do not withdraw or advance the guide wire prior to
withdrawing the Dragonfly Imaging Catheter.
•
Appropriate anticoagulant and vasodilator therapy must be used during
the procedure as needed.
•
Observe all advancement and movement of the Dragonfly Imaging
Catheter under fluoroscopy. Always advance and withdraw the catheter
slowly. Failure to observe device movement fluoroscopically may result
in vessel injury or device damage. To ensure proper placement, do not
move the guide wire after the Dragonfly Imaging Catheter is in place.
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