phenox pNOVUS 27 Instrucciones De Uso página 5

14. Advance the guidewire and microcatheter past the distal part of the guiding catheter.
15. Carefully advance the guidewire and microcatheter to the intended vessel under
fluoroscopy. Advance the guidewire and follow with the microcatheter in an alternate
fashion. (Alternatively, if a larger catheter is used in conjunction with the microcatheter,
follow the microcatheter with the larger catheter).
16. Remove the guide wire from the microcatheter after the target vessel has been reached.
17. Infuse the therapeutic or diagnostic agent or advance the therapeutic or diagnostic device
according to the manufacturer´s description.
18. Lastly, remove the microcatheter carefully under fluoroscopy.
Precautions
• The pNOVUS 27 microcatheter may only be used by physicians thoroughly trained in
percutaneous, intravascular techniques and procedures.
• Only use the device if IFU can be read clearly and can be fully understood and if the label
properly adheres to the packaging.
• Sufficient irrigation of the microcatheter is necessary to remove enclosed air bubbles
• Select the most appropriate microcatheter to treat the lesion. Only insert the
microcatheter into an appropriately sized vessel.
•
Only select compatible guide wires, guide catheters and instruments or agents to be used
with the microcatheter.
• Incorrect steam shaping of the microcatheters may result in deformation or damage of the
hydrophilic coating. Moreover, improper device delivery and deployment may be caused,
depending on the degree of shaping and catheter deflection during device delivery.
• Prior to use, carefully examine the packaging to verify that no damage has occurred
during shipment. Do not use if sterile pack is opened or damaged.
• Inspect the microcatheter prior to use for any damage, surface irregularities, bends or
kinks. Do not use damaged or irregular microcatheters.
• Do not expose the microcatheter to organic solvents, such as disinfection agents, alcohol
or DMSO.
• The shaping mandrel and introducer sheath are not intended for use in the human body.
• Do not exceed 340kPa (50 psi) injection pressure. Excessive pressure may result in
catheter damage, vessel injury or thromboembolism.
•
If there is suspicion of vasospasm in the affected vascular region, all measures required
for reversion should be taken, e.g. with appropriate drug therapy.
• Appropriate premedication with antiplatelet agents and systemic heparinization are to be
considered according to the type and duration of the intervention.
• The microcatheter must only be manipulated under fluoroscopy inside the body.
• Complete immobilization of the patient, e.g. under intubation anesthesia will favorably
affect the treatment.
• Carefully move the microcatheter. Do not attempt to move the microcatheter without
observing the resulting tip response.
• Do not advance the microcatheter if resistance is felt. Stop the procedure. Determine the
cause of the resistance and take appropriate action. If the cause cannot be determined,
withdraw the microcatheter. Excessive force against resistance may result in damage of
the microcatheter, damage or dislodgment of other interventional devices, or vessel injury.
• In case of any unusual microcatheter behavior, stop the procedure and replace the
microcatheter.
•
Avoid blockage of blood flow by the microcatheter.
• If flow through the catheter is hampered, do not try to reestablish flow by forceful flushing.
The catheter must be removed and replaced.
Complications
The following malfunctions of the device and complications, among others, may arise during
or after use of the pNOVUS 27 microcatheter:
• Complications at the puncture site,
• Allergic reaction,
• Death,
•
Embolism (air, foreign body, plaque, thrombus),
• Hematoma,
• Hemorrhage,
• Infection,
•
Interaction of microcatheter with other endovascular devices,
• Ischemia,
• Neurological deficits,
• Pseudoaneurysm,
• Stroke,
• transient Ischemic Attack (TIA),
• Vasospasm,
• Vessel dissection,
• Vessel occlusion,
• Vessel or aneurysm damage, including vessel/aneurysm perforation and rupture,
• Vessel thrombosis.
General information
• Keep away from heat. Store in a cool, dry place.
• Use is only permissible prior to the expiration date, as sterility is not guaranteed
otherwise.
• Intended for single use only. The microcatheter must not be resterilized or reprocessed
for use in other patients since it cannot be cleaned reliably and sterility cannot be ensured
otherwise, or the coating may degrade.
• The device and packaging components, where necessary, must be disposed of following
your institution's procedure for disposal of hazardous waste in appropriately marked
containers.
Symbols
Y
Caution
i
Consult instructions for use
D
Do not reuse
B
Do not resterilize
g
Batch code
yQ
Sterilized using ethylene oxide
L
Do not use if package is damaged
Non-pyrogenic
H
Use-by date
h
Catalogue number
Content
pw
Keep dry. Keep away from sunlight
This product was brought onto the market in accordance
with Directive 93/42/EEC concerning medical devices
M
Manufacturer
Highly flexible distal section
Hydrophilic coated distal section
Inner diameter of microcatheter
Limitation of liability
phenox GmbH shall not be liable for damage caused by use other than that intended or reuse
of the product.
phenox and pNOVUS are registered trademarks of phenox GmbH in the Federal Republic of
Germany and other states.
B840A pNOVUS IFU / 2017-08-28
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