5
12)
The surface of this microcatheter is coated with hydrophilic polymer. Flush the surface and the
lumen of the microcatheter continuously with heparinized and sterilized saline during its use to
maintain lubricity. Flush the lumen of the microcatheter sufficiently with heparinized and
sterilized saline especially after injecting contrast media.
13)
When using a Y-connector, excessive tightening to the microcatheter with the hemostasis valve
and operation with a tightened Y-connector must be avoided. (The microcatheter may be
damaged.)
14)
The microcatheter has not been evaluated for safety and compatibility in the MR environment.
It has not been tested for heating, migration, or image artifact in the MR environment. The
safety of this catheter in the MR environment is unknown. Scanning a patient who has this
device may result in patient injury.
15)
Since this catheter is not designed for use in combination with a power injector, do not use it in
combination with a power injector.
16)
Take preventive measures against infection after use. Discard this product as medical waste.
Malfunction and Adverse effects
During use of this microcatheter, the following malfunction and adverse effects may occur. If the
malfunction and adverse effects are serious, it may induce death or serious complication(s). Note,
however, that malfunction and adverse effects are not limited to these.
1) Malfunction
・
Damage (Separation, Kink, Bend, Deforming, Damage to the hydrophilic coating)
・
Withdrawal difficulty
・
Insertion difficulty
・
Trap with guide wire
2) Adverse effects
・
Death
・
Infection
・
Dissection of blood vessels
・
Perforation of blood vessels
・
Hemorrhagic complication
・
Distal emboli
・
Thrombus
・
Infarction
・
Emborization or vascular damage caused by residue
・
Ischemia
・
Dysrhythmia
・
Spasm of blood vessels
・
Blood pressure reductions
・
Allergic reaction
