Merit Medical Embosphere Microspheres Sterile Vial IFU-Int'l - Manual (Page 6)

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emergent vessels not evident prior to embolization can lead to
mistargeted embolization and severe complications.
• Microspheres smaller than 100 microns will generally migrate distal to
anastomotic feeders and therefore are more likely to terminate
circulation to distal tissue. Greater potential ischemic injury results from
use of smaller sized microspheres and consideration must be given to
the consequence of this injury prior to embolization. The potential
consequences include: swelling, necrosis, paralysis, abscess and/or
stronger post embolization syndrome.
• Post-embolization swelling may result in ischemia to tissue adjacent to
target area. Care must be given to avoid ischemia-intolerant,
nontargeted tissue such as nervous tissue.
INSTRUCTIONS
− Position the catheter at the desired site and perform baseline
angiography to evaluate the blood supply of the lesion.
− Embosphere Microspheres are available in a range of sizes. Because
of the potential for misembolization and the inherent variability in sphere
sizes, the physician should be sure to carefully select the size of
Embosphere Microspheres according to the size of the target vessels at
the desired level of occlusion in the vasculature.
− Carefully select the size of microspheres according to the size of the
vessels identified and the catheter used. Embosphere Microspheres are
flexible particles that support temporary compression by 20 to 30 % to
facilitate passage through microcatheters. Studies have shown a direct
correlation between the size of microspheres and the size of occluded
vessels.
− Check that the packaging is intact. The external surface of the vial is
sterile.
− Gently swirl the opened vial, then pour into a sterile metal/stainless
steel cup.
− It is highly recommended to add contrast agent to monitor the injection
radiologically. Do not exceed a maximum proportion of 50 % contrast
agent – 50 % saline solution! To optimize diffusion of microspheres into
the territory to be embolized, it is recommended to use a fairly dilute
solution.
− To obtain a homogenous mixture, swirl the cup for about one minute.
Do not use the syringe or any other instrument to obtain the suspension,
as this could damage Embosphere Microspheres.
− Draw up the suspension using a small syringe (1 to 3 cc). Check that
the desired quantity and concentration of microspheres are used.
− Under continuous fluoroscopic control, slowly infuse microspheres into
the blood stream. Always inject under free flow conditions. Reflux of
microspheres can induce immediate ischemia of healthy tissues or
vessels.
− Continue infusion until the desired devascularization is obtained.
Studies have shown that Embosphere Microspheres penetrate more
distally into the lesion than PVA particles of similar size. Reduction of the
arterial blood supply to the lesion is therefore more progressive.
− At the end of the infusion, remove the catheter while maintaining
gentle aspiration to avoid dislodging any residual microspheres still
inside the catheter.
− Discard any open vial or unused Embosphere Microspheres.
CONSERVATION AND STORAGE
Embosphere Microspheres must be stored in a cool, dry, dark place in
their original vials and packaging. Use by the date indicated on the labels
of the outer box and blister's pack. Do not freeze.
Information on packaging:
All serious or life threatening adverse events or deaths associated
with use of Embosphere Microspheres should be reported to the
device manufacturer.
Size Range
(µm)
Color Code 1 ml 2 ml
40-120 Orange V110GH V120GH
100-300 Yellow V210GH V220GH
300-500 Blue V410GH V420GH
500-700 Red V610GH V620GH
700-900 Green V810GH V820GH
900-1200 Purple V1010GH V1020GH
Symbol Designation
Manufacturer: Name & Address
Use by date: year-month
LOT Batch code
REF Catalogue number
STERILIZE
2 Do not resterilize
Do not use if package is damaged
Keep away from sunlight
Keep dry
2 Do not re-use
Caution - Refer to Instructions For Use
Non-pyrogenic
STERILE Sterilized using steam
0°C Lower limit of temperature
EC mark logo - Notified body identification : 0459
Biosph_notice Z 1672 rev D 06-12 730034001:Mise en page 1 4/09