Terumo Ryujin Plus Mode D'emploi page 19

4. Complications
Possible complications of PTCA include, but are not limited to, the following:
· Coronary artery dissection
· Acute myocardial infarction
· Ventricular fibrillation
· Ischaemia due to long-term dilatation
· Arterial perforation
· Arteriovenous fistula
· Palpitation
· Hypotension
· Coronary artery injury
· Unstable angina pectoris
· Intravessel thrombosis
· Arterial rupture
If a complication requiring emergency coronary artery bypass surgery has occured as the result of PTCA,
the mortality of patients who had previous bypass surgery will be higher than that of patients who did not
undergo bypass surgery. The long term complications of PTCA remain to be defined.
5. Precautions for application
• This product has been sterilized by ethylene oxide gas. For single use only. Do not reuse. Do not resterilize. Do
not reprocess. Reprocessing may compromise the sterility, biocompatibility and functional integrity of the device.
• Sterile and non-pyrogenic in an unopened and undamaged unit package. Do not use if the unit package or the
product have been damaged or soiled.
• The product should be used immediately after opening the package and be disposed of safely and properly after
use.
• The dilatation catheter should be used by a physician who is familiar with, and well trained in, PTCA techniques.
Failure to observe this warning could result in failure due to improper operation.
• PTCA procedures should be carried out only at institutions where emergency coronary artery surgery can be
performed preparing for severe complications. It is desirable that a cardiovascular surgery team is standing ready
during PTCA procedures. Otherwise failure or complications cannot be promptly responded to.
• Do not soak the catheter in sterilizing alcohol or drug solutions containing organic solvents, or wipe the catheter
with drugs. Failure to observe this warning could damage or break the catheter or cause loss of lubricity.
• Any advancement after introduction of the dilatation catheter into the vessel should be done under high resolution
fluoroscopy.
• The entire operation should be carried out aseptically.
DIRECTIONS FOR USE
• Before using the catheter, read the instructions for the accompanying pharmaceutical
CAUTIONS
• Before use, confirm that all apparatus including the dilatation catheter is functioning
1. Preparation of the dilatation catheter
1-1 Carefully remove the catheter from the holder tube.
CAUTIONS
1-2 After wetting the balloon protection sheath with physiological saline solution, carefully remove the balloon
protection sheath and stylet not to damage the balloon part.
CAUTION
1-3 Draw 3 mL of an appropriate contrast media (for example: a 1:1 mixture of contrast media and physiological
saline solution) into a 20 mL syringe.
WARNING
1-4 Connect the syringe containing contrast media to the balloon inflation port of the dilatation catheter.
1-5 Holding the syringe with its tip down, aspirate air for 15 seconds.
1-6 While holding the syringe with its tip pointing downwards, inject the contrast media slowly.
1-7 Repeat steps 1-5 and 1-6 several times until contrast media fills the balloon completely.
products and medical devices.
properly. Confirm whether the dilatation catheter is damaged or not, and that the design of
the balloon meets the criteria of the procedure and the technique to be used.
• Remove the catheter in a straight line from the end of the holder tube without bending
the catheter.
• Do not remove the catheter by force if resistance is encountered. Forcible removal could
cause the balloon not to inflate or deflate.
Do not remove the sheath if resistance is felt. Using force may result in damage to the
balloon.
Do not use air, gases or liquids other than contrast media to inflate the balloon. In
case of leakage from the balloon, such fluids could have serious adverse effects on
the patient's health.
· Infection and pain at the insertion site
· Bradycardia
· Severe arrhythmia
· Cerebral infarction
· Total occlusion of coronary artery or bypass graft.
· Restenosis of coronary artery
· Ischaemia due to spasm
· Distal embolization
· Haematoma
· Nausea and vomiting
· Haemorrhage
· Death
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