Directions For Use - Terumo Hiryu Manual Del Usuario

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

CAUTIONS
1. Preparation of the dilatation catheter
1-1 Carefully remove the catheter from the holder tube.
CAUTIONS
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solution. Before reinserting the same balloon catheter, inspect the entire
catheter to ensure that neither the lubricity of the surface has decreased,
nor any foreign substances are on the catheter. To remove the blood from
the guide wire lumen, flush the catheter with heparinized physiological
saline solution.
• Before using the catheter, read the instructions for the accompanying
pharmaceutical products and medical devices.
• Before use, confirm that all apparatus including the dilatation catheter is
functioning 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. If the catheter is not removed in a straight
line, excessive pressure is applied to the area near the guide-wire port,
possibly damaging or breaking the catheter.
• Do not remove the catheter by force if resistance is encountered. Forced
removal could cause the balloon not to inflate or deflate.
· 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