4
19)
Injection pressure must not exceed the maximum injection pressure when injecting contrast
media. Exceeding the injection pressure beyond the maximum injection pressure may cause
damage to the microcatheter.
20)
When infusing contrast media, the device must be operated with confirming that the contrast
media is being infused from the tip of the device. If the contrast media is not being infused,
infusion must be stopped and the device must be replaced with a new one.(If the device lumen is
occluded, the device may be dilated, damaged, or ruptured even at not more than the maximum
injection pressure, resulting in a life-threatening adverse event due to spurting contrast media.)
21)
Do not use guide wires larger than the recommended size. (Resistance may be felt while
advancing or withdrawing a guide wire larger than the recommended size, which may cause the
microcatheter to become damaged or break, or the blood vessel to become damaged. In the
worst case, life-threatening adverse events may occur.)
22)
If the microcatheter is inserted into vessels and the guide wire is to be replaced, insert the guide
wire carefully. If there is any resistance during operation, the operation must be discontinued
immediately, and the microcatheter and the guide wire are withdrawn together. (The
microcatheter may be damaged and the tip may be cut.)
23)
Repeated insertion and withdrawal of this microcatheter may lead to deterioration of the
hydrophilic coating. (Continuous use of the device with deteriorated hydrophilic coating may
cause vascular damage. This may also increase the risk of trapped tip, resulting in a life-
threatening adverse event due to a damage and/or separation of tip.)
24)
Comply with instructions, precautions, and warnings described in the Instructions for Use
supplied with medical devices (Namely, Sheath introducer kit, Angiographic catheter, Guiding
catheter, Guide wire) and contrast media used together with the microcatheter.
Precautions
1)
Do not use if the package is opened or damaged. Always open the package just prior to use.
2)
Prior to use, check all devices, including this microcatheter, and confirm that they function
normally. Check also if the microcatheter is not damaged during transportation. Do not use if
the package and/or the microcatheter is suspected to be damaged.
3)
Use immediately after opening the bag. After use, discard it respecting the disposal policies and
infection controls.
4)
When inserting the guide wire into the microcatheter which is already placed in the blood vessel,
carefully operate the guide wire not to damage the microcatheter at the bend sections.
5)
Agents containing organic solvent such as alcohol must not be used either alone or concurrently.
These agents must not be used for immersing or wiping the device. (The catheter may be
damaged or lose its lubricity.)
6)
Confirm that this microcatheter does not have a kink, knot, torsion, or occlusion before injecting
contrast media.
7)
Do not use this microcatheter for the purposes other than described in the Indications for Use
written in this document.
8)
Select the appropriate size of guiding catheter and guide wire to use in combination with this
microcatheter. (See the label of product package)
9)
When using a guiding catheter fitted with a stopcock, do not manipulate the stopcock after
inserting this microcatheter into the guiding catheter. (If the stopcock is manipulated during the
insertion of this microcatheter, this microcatheter may be broken.)
10)
Operate the microcatheter carefully to avoid damage, kinking, or bending, especially when
inserting this microcatheter into the guiding catheter.
11)
Check the patient’s condition before the procedure. Provide appropriate anticoagulant therapy if
it is necessary.
