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Complications related to catheterization (e.g. hematoma at the site of entry,
clot formation at the tip of the catheter and subsequent dislodgment, and
nerve and/or circulatory injuries, which may result in leg injury)
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Allergic reaction to medications (e.g. analgesics)
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Allergic reaction to contrast media or embolic material
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Pain and/or rash, possibly delayed from the time of embolization
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Death
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Blindness, hearing loss, loss of smell, and/or paralysis
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Neurological deficits, including cranial nerve palsies
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Additional information is found in the Warnings section
STORAGE & STERILITY
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EmboCube Embolization Gelatin must be stored at room temperature in
a dry and dark place in their original packaging.
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Use by the date indicated on the labeling.
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Do not resterilize.
CLINICAL PROCEDURE
The EmboCube Embolization Gelatin should be used by physicians trained on
the procedures for which the device is intended. The techniques and procedures
described do not represent ALL medically acceptable protocols, nor are they
intended as a substitute for the physician's experience and judgment in treating
any specific patient. All available data, including the patient's signs and symptoms
and other diagnostic test results, should be considered before determining
a specific treatment plan.
INSTRUCTIONS FOR USE
1.
Prior to use, carefully inspect the EmboCube Embolization Gelatin
packaging and components for damage.
2.
Utilizing sterile technique, remove the EmboCube Embolization Gelatin
from its packaging and transfer to the sterile field.
3.
Carefully evaluate the vascular network associated with the lesion using
high resolution imaging prior to beginning the embolization procedure.
4.
Choose the appropriate size of EmboCube Embolization Gelatin that best
matches the pathology (i.e., vascular target/vessel size) and provides the
desired clinical outcome.
5.
Choose a delivery catheter based on the size of the target vessel and the
EmboCube Embolization Gelatin size being used.
6.
Introduce the delivery catheter into the target vessel according to standard
techniques. Position the catheter tip as close as possible to the treatment
site to avoid inadvertent occlusion of normal vessels.
7.
Use caution in targeting the appropriate vessel or embolization endpoint.
8.
Prepare the EmboCube Embolization Gelatin according to the following
steps:
A. Take an empty 10 mL syringe and aspirate 5 mL of contrast and 5 mL
of 0.9% NaCl and connect it to the inline port of a luer lock 3-way
stopcock.
B. Remove any air in the saline/contrast syringe and 3-way stopcock by
slowly pushing the syringe plunger while the syringe tip is vertically
upright.
C. Turn the 3-way stopcock to close the syringe with saline and contrast.
D. Firmly compress the EmboCubes with the syringe plunger tip to
remove air from the EmboCubes.
E. Attach the EmboCube syringe to the side port of the 3-way stopcock.
F.
Open the 3-way stopcock to allow for transfer between the EmboCube
syringe and the saline/contrast syringe and slowly transfer the saline/
contrast solution into the EmboCube syringe.
G. Slowly make two to five back and forth transfers in the syringes to
hydrate the EmboCubes.
H. Remove the 10-mL empty syringe and attach a 1 mL or 3 mL injection
syringe to the 3-way stopcock.
I.
Draw the EmboCube Embolization Gelatin saline/contrast mixture
into the injection syringe slowly and gently to minimize the potential
of introducing air into the system.
J.
Purge all air from the system prior to injection.
K. Injec t the EmboCube Embolization Gelatin saline/contrast
mixture from the delivery syringe into the delivery catheter under
fluoroscopic visualization using a slow pulsatile injection while
observing the contrast flow rate.
L. Repeat the delivery process with additional injections of the
EmboCube Embolization Gelatin saline/contrast mixture until the
desired embolization endpoint is reached.
M. Consider using larger sized EmboCube Embolization Gelatin if the
initial injections do not alter the contrast flow rate.
9.
Upon completion of the treatment, remove the catheter while maintaining
gentle suction so as not to dislodge any residual EmboCube Embolization
Gelatin still within the catheter lumen.
10. Discard any open, unused EmboCube Embolization Gelatin.
INFORMATION ON PACKAGING (SYMBOLS)
Manufacturer: Name and Address
Use by date: year-month-day
LOT
Batch code
REF
Catalog number
Do not resterilize
Do not use if package is damaged
Keep away from sunlight
Keep dry
Do not reuse
Single Use
Caution: Consult accompanying documents.
Read instructions prior to use.
Non-pyrogenic
Sterilized Irradiation
All serious or life-threatening adverse events or deaths associated with use of
EmboCube Embolization Gelatin 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 Merit Medical,
Inc. can be made by calling toll free 800-394-0295.
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