Product Description - phenox pNOVUS 27 Instrucciones De Uso

ENGLISH
INSTRUCTIONS FOR USE
Manufacturer
phenox GmbH
Lise-Meitner-Allee 31
44801 Bochum, Germany
Phone: +49 234 36 919 0
Fax: +49 234 36 919 19
Package contents
1 x microcatheter
1 x shaping mandrel
1 x introducer sheath
1 x packaging card including ruler

Product description

pNOVUS 27 is a single lumen microcatheter. The catheter exhibits variable stiffness. The
flexibility decreases from distal to proximal, ranging from highly flexible at the distal part to
semi-rigid at the proximal end.
The distal outside section has a hydrophilic coating to enhance lubricity. A Polytetrafluorethylene
(PTFE) liner ranging from the distal tip to the proximal end facilitates introduction and movement
of compatible devices inside the catheter.
A radiopaque marker near the distal tip allows for fluoroscopic visualization while advancing
inside the body.
A standard Luer adapter at the proximal end facilitates attachment of accessories.
The pNOVUS 27 microcatheter has a straight tip. Steam shaping of the distal tip allows for
one-time, permanent customizing of the shape.
The optional usable accessories, a shaping mandrel, an introducer sheath and a ruler, which is
printed on the packaging card, are delivered inside the sterile pouch.
The product is provided in single packaging.
Design of pNOVUS 27 microcatheter.
Fig. 1: Schematic Drawing of pNOVUS 27
A Working length
B Total length
C Distal flexible part
D Length of the distal part
E Hydrophilic coating
F Inner diameter
G Outer diameter distally
H Outer diameter proximally
Distance of distal tip to radiopaque
J
marker
K Tip shape
L Hub with Luer lock
M Strain relief
Intended Use
The intended use of pNOVUS 27 is to support the stable access of suitable therapeutic or
diagnostic devices, i.e. devices compatible with the inner diameter of the microcatheter, and
the infusion of therapeutic and diagnostic agents.
The microcatheter is commonly inserted percutaneously into the femoral artery through a
sheath or guide catheter.
If transvenous access is desired, a sheath is introduced into a suitable venous access site
(such as the femoral vein).
Time for use is transient. Therefore, the device is normally intended for continuous use of less
than 60 minutes.
The microcatheter can also be used to guide a catheter with larger inner diameter.
Indications
The pNOVUS 27 microcatheter is intended for the delivery of diagnostic agents (such as
contrast media), therapeutic agents (such as antiplatelet or vasodilating drugs) and non-liquid
interventional devices (such as stents) to intra-and extracranial brain-supplying arteries and
intra- and extracranial brain-draining veins.
B840A pNOVUS IFU / 2017-08-28
4
hydrophilic
flexible
150 cm
157 cm
8 cm
33 cm
80 cm
0.028 inch / 0.71 mm
2.8F / 0.95 mm
2.9F / 0.96 mm
(max. 1.03 mm / 0.0406 inch)
0.7 mm
Straight, shapeable, 1 radiopaque
marker
Contraindications
The pNOVUS 27 microcatheter is contraindicated with known generalized vessel wall
weakness and in coronary vessels.
The device is contraindicated for use in patients with contraindications for whichever
accompanying medication is necessary.
Compatibility
Agents and devices used with the pNOVUS 27 microcatheter must be compatible with the
microcatheter's dimensions according to the manufacture's description.
The pNOVUS 27 microcatheter is not compatible with glue, glue mixture or non-adhesive
liquid embolic agents.
pNOVUS 27 is compatible with the following products:
•
Guidewire with a maximum outer diameter of 0.018 inch/0.46 mm,
•
(Guide) Catheter with a minimum inner diameter of 0.053 inch/1.35 mm,
•
Non-liquid interventional devices (such as stents), which are declared compatible to a
microcatheter with an inner diameter of 0.027 inch according to the respective IFU,
• In particular, pNOVUS 27 is compatible with the phenox products p64, pCONUS,
pRESET, pCANVAS, and pORTAL,
• Rotating hemostatic valves (RHV) with standard Luer adapter.
Recommended procedure
Preparation for use
1. Flush the hoop with sterile saline through the Luer fitting connected to the end of the
packaging hoop before removing the microcatheter. Hydrate for at least 30 seconds.
2. Carefully withdraw the microcatheter from the hoop.
3. Inspect the microcatheter thoroughly to ensure that it is not irregular or damaged. If the
microcatheter is irregular or damaged replace the device.
4. Flush the inner lumen of the microcatheter with sterile saline.
5. Do not allow the catheter to dry once hydrated or after secondary shaping.
Secondary shaping
A steam shaping mandrel is packed with the pNOVUS 27 microcatheter in order to allow for
shaping of the microcatheter tip.
Warning: The steam shaping mandrel is not intended for use in the human body. The following
instructions should strictly be followed to maintain the integrity of the inner diameter of the
microcatheter!
Remove the shaping mandrel from its packaging
1.
Insert the shaping mandrel's entire working length into the microcatheter's distal lumen.
2.
Flush or dip the microcatheter tip into sterile saline to aid the mandrel's movement.
Carefully bend the shaping mandrel and distal catheter portion into the desired shape.
3.
A slight exaggeration may be required to account for catheter relaxation.
Shape the catheter by holding the shaped portion in front of a steam source for
4.
approximately 30 seconds. Hold the catheter no closer than 2.54 cm (1 inch) from the
steam source.
Before removing the mandrel, allow the catheter tip to cool in air or saline. Remove the
5.
mandrel and discard. Flush the catheter lumen after removal of the mandrel.
Multiple shaping is not recommended.
6.
Inspect the catheter tip for damage that may have resulted from steam shaping. If
7.
damage is found, do not use the catheter.
Direction for use
1. Gather and document a case history as complete as possible, especially regarding
the history of the present illness, comorbidities, previous interventions and current
medication according to standard of care.
2. As far as possible, inform the patient and document the patient's consent to
the planned intervention, pointing out the possible complications and potential
consequences (disability, care dependency or death). In cases where patients cannot
give consent themselves, their relatives should, as far as possible, be asked if they
know what the presumed patient's will would be. Otherwise, in case of emergency,
the rules of emergency care for incapacitated patients apply, subject to different
institutional or national requirements.
3. Introduce a suitable catheter sheath into an appropriate vessel according to standard
practice/ the respective IFU.
4. Flush the guide catheter prior to use. Connect the rotating hemostatic valve (RHV)
and continuous pressure infusion to the guide catheter.
5. Insert the guide catheter into an appropriate vessel according to standard practice.
(Alternatively, in case a long sheath is used, the procedure may be conducted without
an additional guide catheter)
6. Flush the microcatheter as described above in the section "Recommended
procedure/preparation for use".
7. If desired, shape the microcatheter tip as described above in the section
"Recommended procedure/secondary shaping".
8. Connect the RHV and continuous pressure infusion to the microcatheter.
9. Prepare the guidewire according to the respective IFU.
10. Carefully insert the guidewire into the microcatheter. If desired, the guidewire-
microcatheter assembly may be inserted into a compatible larger catheter (min. inner
diameter of 0.053 inch/1.35 mm, as e.g. an aspiration catheter).
Introduce the catheter-wire assembly through the guiding catheter's RHV using the peel
11.
away introducer sheath. Tighten the O-ring valve around the microcatheter just enough
to prevent back flow, but not so tight as to inhibit microcatheter movement. Warning:
Excessive tightening of the hemostatic valve around the microcatheter may lead to
damage of the device.
12. Remove the introducer sheath from the microcatheter-guidewire assembly by retracting
the introducer from the RHV and peeling it off. Warning: Removing the introducer
sheath from the microcatheter without a guidewire inserted may cause damage to the
microcatheter.
13. Maintain continuous flush in the microcatheter and guide catheter.