INTENDED USE:
QuadraSphere
®
Microspheres are indicated for
embolization of hypervascularized tumors and peripheral
arteriovenous malformations.
DESCRIPTION:
QuadraSphere Microspheres are part of a family of embolic
agents based on proprietary technologies. They are
designed for controlled, targeted embolization.
QuadraSphere Microspheres are biocompatible,
hydrophilic, non-resorbable, expandable, and conformable
microspheres. QuadraSphere Microspheres swell upon
exposure to aqueous solutions. They are available in a
range of sizes.
DEVICE PACKAGING:
QuadraSphere Microspheres are contained in a sterile, 10
ml Cyclic Olefin Copolymers (COC) vial, with a crimped cap,
packaged in a sealed pouch.
Contents: 25 mg (nominal) of dry QuadraSphere
Microspheres per vial to be reconstituted in NaCl 0.9%
aqueous solution before use (or aqueous solution of
equivalent ionic concentration).
CONTRAINDICATIONS:
• Patients intolerant to vascular occlusion procedures
• Vascular anatomy or blood flow precluding correct
catheter placement or embolic injection
Note:
Vigorous shaking may introduce micro bubbles,
which can cause the microspheres to aggregate.
• Wait a minimum of 10 minutes
to allow the QuadraSphere
Microspheres to reconstitute and expand fully.
• Use a 30ml syringe and 20 gauge or larger needle to
aspirate the contents of the vial. Rotate the vial to a vertical
position with the bottom of the vial facing upward. Pull the
needle back so that it is submerged in the liquid but not
occluded by the stopper. Gently aspirate the entire contents
of the vial into the syringe.
Note:
If the air was previously aspirated from the vial,
gentle injection of air using the syringe prior to aspirating
the contents of the vial will ensure an easier aspiration of
vial contents into the syringe. If all contents are not
withdrawn, introduce an additional volume of air and repeat
the aspiration process. It is possible to add an additional
amount of non-ionic contrast or NaCl 0.9% aqueous
solution into the syringe in order to get a higher dispersion
of microspheres.
• If microspheres were reconstituted using 100% NaCl
0.9%, non-ionic contrast medium must be added to the
syringe containing the QuadraSphere Microspheres for
visualization under fluoroscopy. If non-ionic contrast
medium was used to reconstitute the microspheres,
additional non-ionic contrast medium may be added.
DELIVERY INSTRUCTIONS:
• Carefully evaluate the vascular network associated with
the target lesion utilizing high resolution imaging.
Note:
It is important to determine if any arteriovenous
shunts are present before beginning embolization.
• Using standard techniques, position the delivery catheter
within the target vessel and the catheter tip as close as
possible to the embolization target.
• Use an injection syringe no larger than 3ml for the
delivery of QuadraSphere Microspheres. Use of a 1ml
injection syringe is recommended.
• Aspirate 1ml of the QuadraSphere Microspheres mixture
into the injection syringe.
• Two methods for embolic aliquot sequestering for
injection may be used:
- Option 1:
Connect a 3 way-stopcock to the 30ml syringe
containing the QuadraSphere Microspheres to the infusion
micro catheter and use a 1ml syringe for injection through
the open port of the 3 way-stopcock.
- Option 2:
Serial aliquots of QuadraSphere Microspheres
can be drawn from the 30ml syringe into a 1ml injection
syringe through a 3 way-stop cock that is not attached to
the infusion catheter. The 1ml syringe containing each
aliquot can be attached independently to the infusion
microcatheter and injected.
• Invert the 30ml syringe back and forth to maintain the
homogenous suspension of the QuadraSphere
Microspheres mixture.
• Under continuous fluoroscopic guidance, inject the aliquot
of QuadraSphere Microspheres in a slow, non forceful,
pulsatile manner over a time period of approximately 1
minute per ml of microspheres solution. Always inject under
free-flow conditions and monitor for reflux.
Note:
Reflux of embolic spheres can induce immediate
ischemia of untargeted tissues and vessels.
• When stasis in the feeding pedicle occurs while delivering
the QuadraSphere Microspheres, wait a minimum of 5
minutes then perform a selective angiogram after the full 5
minutes wait to verify the cessation of antegrade flow.
• If cessation of antegrade flow has not occurred, continue
infusion under fluoroscopic guidance until the desired
devascularization is obtained.
• After the QuadraSphere Microspheres infusion is
completed, remove the catheter while maintaining gentle
aspiration to avoid dislodging any residual QuadraSphere
Microspheres that may still be in the catheter lumen.
Discard the catheter after removal and do not reuse.
• Discard any open vial or unused QuadraSphere
Microspheres.
CAUTION:
In the event that the catheter becomes obstructed or
significant infusion resistance is encountered during
injection, do not attempt to flush the catheter with
excessive pressure because reflux of embolic material may
occur resulting in untargeted embolization. Remove the
catheter while applying gentle aspiration and discard.
CONSERVATION AND STORAGE:
QuadraSphere Microspheres must be stored in a dry, dark
place in their original vials and packaging. Use by the date
indicated on the labels of the outer box.
When the procedure of reconstitution is completed, store
the solution of QuadraSphere Microspheres in 2 to 8°C
conditions and use within 24 hours, IF not used
immediately. Do not store QuadraSphere Microspheres after
contrast medium has been added.
Information on packaging:
QuadraSphere Microspheres is a registered trademark of
BioSphere Medical.
All serious or life-threatening adverse events or deaths
associated with use of QuadraSphere Microspheres should
be reported to the U.S. Food and Drug Administration under
the MedWatch program and to the device manufacturer.
Information about the MedWatch program and forms for
reporting adverse events can be obtained at
www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm
or by calling toll free 888-463-6332. Reports to BioSphere
Medical, Inc. can be made by calling toll free 800-394-
0295.
Symbol
Designation
Manufacturer: Name & Address
Use by date: year-month
LOT
Batch code
REF
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