Merit Medical Embosphere Microspheres Prefilled Syringe IFU-Int'l - Manual (Page 4)

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
of 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.
• Inspect packaging and syringe before use to ensure that
they are intact. The external surface of the syringe is sterile.
• Unscrew the cap of the Embosphere Microsphere prefilled
syringe and gently draw contrast agent directly into the
reservoir syringe.
• The ideal suspension is usually obtained with a mixture of
50% contrast agent and 50% saline solution. To obtain a
homogeneous suspension of Embosphere Microspheres,
gently invert the 20-ml syringe several times. Contrast agent
and 0.9% NaCl solution can be added in the same proportions
to obtain a more diluted suspension.
• Do not use the 20-ml prefilled syringe to inject
Embosphere Microspheres through the catheter!
• Remove all air from the syringe and connect it to one hub of
the three-way stopcock.
• Draw up the suspension using a small syringe (1 to 3 cc)
connected to another hub of the three-way stopcock. Avoid
back and forth movements to reduce the risk of introducing air
into the system. Check that the desired quantity and
concentration of microspheres are used.
• Remove all air from the syringe.
• Screw the syringe onto the hub of the catheter, using the
male Luer-lock connector of the stopcock.
• Open stopcock to connect the injection syringe with the
catheter.
• Under continuous fluoroscopic control, slowly infuse
microspheres into the blood stream. Always inject under free
flow conditions. Reflux of microspheres can induce immediate
ischaemia of healthy tissues or vessels.
• Continue infusion until the desired devascularisation 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, then close the three-way
stopcock.
• Remove the catheter.
• Discard any remaining Embosphere Microspheres and the
used syringes.
• Do not use the 20-ml prefilled syringe to inject
Embosphere microspheres through the catheter!
• Remove all air from the syringe and connect it to one hub of
the three-way stopcock.
• Draw up the suspension using a small syringe (1 to 3 cc)
connected to another hub of the three-way stopcock. Avoid
back and forth movements to reduce the risk of introducing air
into the system. Check that the desired quantity and
concentration of microspheres are used.
• Remove all air from the syringe.
• Screw the syringe onto the hub of the catheter, using the
male Luer-lock connector of the stopcock.
• Open stopcock to connect the injection syringe with the
catheter.
• Under continuous fluoroscopic control, slowly infuse
microspheres into the blood stream. Always inject under free
flow conditions. Reflux of particles can induce immediate
ischaemia of healthy tissues or vessels.
• Continue infusion until the desired devascularisation 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, then close the three-way
stopcock.
• Remove the catheter.
• Discard any remaining Embosphere microspheres and the
used syringes.
CONSERVATION AND STORAGE
Embosphere Microspheres must be stored in a cool, dry, dark
place in their original syringe 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.
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
Sterilized using steam
0°C Lower limit of temperature
EC mark logo - Notified body identification : 0459
STERILE
4
Size Range
(µm)
Color Code 1 ml 2 ml
40-120 Orange S110GH S120GH
100-300 Yellow S210GH S220GH
300-500 Blue S410GH S420GH
500-700 Red S610GH S620GH
700-900 Green S810GH S820GH
900-1200 Purple S1010GH S1020GH