phenox p64 MW Instrucciones De Uso página 7

• For flushing place the introducer sheath of the p64 MW (HPC) inside the hemostatic valve of the
microcatheter and flush it by the help of the connected irrigation fluid. Thorough flushing of the introducer
sheath is essential in order to remove any trapped air bubbles.
• All manipulations must be carried out under fluoroscopic visualization.
• If the p64 MW (HPC) system is advanced beyond the distal end of the microcatheter, the vessel may be
dissected or perforated.
• If the p64 MW (HPC) system can be advanced into the microcatheter only with great effort or navigated
through the microcatheter only with great effort, remove the entire p64 MW (HPC) system out of the
microcatheter as a precaution.
• Do not pull the deployed implant back through the vessel into the microcatheter. Instead, push the
microcatheter over the p64 MW (HPC) while simultaneously fixating the delivery system to reposition
and redeploy the implant if necessary.
• The p64 MW (HPC) is a delicate implant and requires careful handling. Never push the microcatheter
onto the p64 MW (HPC) against resistance. Never twist the delivery system. If necessary, remove the
p64 MW (HPC) along with the microcatheter.
• Forceful pulling or pushing or twisting on the delivery system may inadvertently detach the p64 MW
(HPC) from the delivery system. In such a case, recovery with a foreign body retrieval device
(e.g. Microsnare Kit, ev3/Covidien/Medtronic) is recommended.
• Extreme stress to the delivery system tip could lead to separation of some of its parts. In such cases,
recovery with a foreign body retrieval device (e.g. Microsnare Kit, ev3/Covidien/Medtronic) is recommended.
• If there is the risk that the patient is unresponsive or not fully responding to dual antiplatelet therapy, the
time between implant deployment and detachment is supposed to be as short as possible to avoid any
insufficient deployment of proximal implant end by bonding of braiding wires caused by blood ingredients
(e.g. fibrin).
Any additional treatment (e.g. coiling of the aneurysm while the associated microcatheter is "jailed" by the
deployed p64 MW (HPC)) is supposed to be done after p64 MW (HPC) detachment.
• Do not detach the implant in case of poor wall apposition or if the implant is in a stretched condition.
Improve expansion by re-deploying or removing/replacing the device.
• If not all the implant's braiding wires emerge from the soft pad at the distal end of the transport tube,
careful movement of the delivery system helps to loosen them.
• Time between start of implant deployment and complete deployment resulting in a detachment must be
as short as possible, in order to prevent any bonding effects by blood ingredients and ultimately poor
proximal implant deployment.
• Insufficient deployment of the proximal implant end can be improved by manipulation with the delivery
system, the microcatheter, or means of a subsequent balloon dilatation. If the proximal end of the
p64 MW (HPC) does not open, recovery with a foreign body retrieval device (e.g. Microsnare Kit,
ev3/Covidien/Medtronic) is recommended.
• If vasospasm is suspected in the affected vascular region, all necessary measures, e.g. medication,
should be used to aid regression prior to implantation.
• For delivery wire withdrawal use a separate torque device locked to the delivery wire. A suitable torquer is
compatible with microguidewires that are 0.014 or 0.016 inches (0.36 or 0.41 mm) in diameter.
• If the torquer cannot be removed from the transport tube (by unscrewing and pulling it in the proximal
direction), unscrew the torquer device completely. A higher resistance may be felt prior to complete
separation of torquer handle and cap. Remove the torquer handle while the torquer cap and inlay stay in
place. Then continue using the separate torque device for the process of delivery wire withdrawal.
• If the implant cannot be detached or is not supposed to be detached after torquer release after the delivery
wire was moved proximally and the p64 MW (HPC) implant needs to be removed, gently place the delivery
wire again distally to enable that then the microcatheter can recover implant and delivery wire tip.
• If the distal marker of the transport tube displaces by the movement of the delivery wire, remove the entire
p64 MW (HPC) system considering the above mentioned precautions.
• Patients with known hypersensitivity to nickel-titanium materials may suffer an allergic reaction to the implant.
• Certification: The implant may only be used by specialized and appropriately trained physicians.
Completion of a product training course run by phenox GmbH is a prerequisite for the use of the
p64 MW (HPC). At least three (3) interventions using the p64 MW (HPC) must be supervised by
a physician or other qualified person delegated by phenox GmbH, and their course and outcome must
be documented.
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.
• Do not use if packaging is damaged, as sterility cannot be assumed otherwise.
• The device must be checked for damage before use. Do not use deformed or damaged devices,
as function cannot be assumed otherwise.
• The product is intended for single use only. The implant must not be withdrawn into its introducer sheath,
resterilized or reprocessed for use in other patients since it cannot be cleaned reliably.
• The delivery system and, where necessary, packaging components must be disposed of appropriately
in marked containers.
Complications
The following complications, amongst others, may arise during or after implantion:
• Air embolism, embolism in distal vessels, vessel occlusion, thrombosis and cerebral ischemia
• Perforation, rupture, dissection and other arterial lesions
• Occlusion of side branch/perforator
• (Transient) stenosis of target vessel
• Vasospasm, occurrence of a pseudoaneurysm, intracranial hemorrhage
• Reccurrence of aneurysm, retreatment of aneurysm
• Allergic reaction, infection
• Space-occupying infarction, neurological deficit including the consequences of a stroke
• Persistent vegetative state, death
Magnetic resonance imaging
Non-clinical tests have shown that the p64 MW (HPC) is suitable for MRI at a magnetic flux density of 3T.
Under clinical conditions, 1.5T has proven to be unproblematic for the implant.
Symbols and their meaning
Symbols on the label:
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
Catalog 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
MAT
Material: NiTi (Nickel Ttitanium alloy)
NiTi
Latex-free
Phthalate-free
Limitation of liability
phenox GmbH shall not be liable for damage caused by use other than that intended of the product.
phenox and p64 are registered trademarks of phenox GmbH in the Federal Republic of Germany and
other states.
B871B p64 MW IFU / 2019-12-17 7