Merit Medical EmboCube EC2525 Mode D'emploi page 2

EmboCube™
Embolization Gelatin
I N S T R U C T I O N S F O R U S E
INTENDED USE
EmboCube Embolization Gelatin is indicated for use in embolization
of blood vessels to occlude blood flow for controlling bleeding/
hemorrhaging.
EmboCube Embolization Gelatin occludes vessels up to 5 mm.
EmboCube Embolization Gelatin is intended to be used in adults.
DEVICE DESCRIPTION
EmboCube Embolization Gelatin consists of biocompatible, hydrophilic
and dry pre-cut cubes of resorbable porcine gelatin packaged in a 10 mL
syringe with a standard luer lock tip.
MAGNETIC RESONANCE IMAGING
EmboCube Embolization Gelatin is made of porcine gelatin and has no
ferrous composition.
SPECIFICATIONS
EmboCube Embolization Gelatin is sold in two sizes (2.5 mm and 5.0
mm) and three weight configurations with the specification for each size
listed below:
Order Weight Cube Recommended
Number Hydrated Injection Syringe
Size
EC2525
25 mg 2.5 mm
EC2550 50 mg 2.5 mm
EC25100 100 mg 2.5 mm
EC5025
25 mg 5.0 mm
EC5050
50 mg 5.0 mm
EC50100 100 mg 5.0 mm
Based on an animal model, EmboCube Embolization Gelatin showed
significant resorption by week 4.
CONTRAINDICATIONS
• Patients unable to tolerate vascular occlusion procedures
• Vascular anatomy precluding correct catheter placement
• Feeding arteries too small to accept the selected EmboCube
Embolization Gelatin
• Presence or suspicion of vasospasm
• Coronary and intracerebral vascular use
• Presence of distal arteries directly supplying cranial nerves
• Presence of patent extra-to-intracranial anastomoses
• High-flow arteriovenous shunts or with a diameter greater than the
selected EmboCube Embolization Gelatin
• Use in the pulmonary vasculature
• Use in pre-operative portal vein embolization (PVE)
• Severe atherosclerosis
• Patients with known allergy to gelatin
WARNINGS
• EmboCube Embolization Gelatin contains gelatin of porcine origin,
and therefore, could cause an immune reaction in patients who are
hypersensitive to collagen or gelatin. Careful consideration should
be given prior to using this product in patients who are suspected
to be allergic to gelatin.
• Care must be taken when embolizing arteriovenous malformations
with large shunts to avoid passage of the embolic into the
pulmonary or coronary circulation.
• The physician should be sure to carefully select the size of
EmboCube Embolization Gelatin according to the size of the
catheter appropriate for the target vessels at the desired level
of occlusion in the vasculature and after consideration of the
arteriovenous angiographic appearance. Size should be selected to
prevent passage from artery to vein.
English
Minimum Color
Catheter ID Code
Volume
1 mL 0.024" Green
(0.61 mm)
1 mL 0.024" Green
(0.61 mm)
1 mL 0.024" Green
(0.61 mm)
3 mL 0.040" Red
(1.02 mm)
3 mL 0.040" Red
(1.02 mm)
3 mL 0.040" Red
(1.02 mm)
• Because of the significant complications of non-target embolization,
extreme caution should be used for any procedures involving the
extracranial circulation encompassing the head and neck, and the
physician should carefully weigh the potential benefits of using
embolization against the risks and potential complications of the
procedure. These complications can include blindness, hearing
loss, loss of smell, paralysis and death.
• If air is not fully purged from the system prior to injection air
embolism may occur.
• Serious radiation induced skin injury may occur to the patient due
to long periods of fluoroscopic exposure, large patient diameter,
angled x-ray projections, and multiple image recording runs or
radiographs. Refer to your facility's clinical protocol to ensure the
proper radiation dose is applied for each specific type of procedure
performed. Physicians should monitor patients that may be at risk.
• Onset of radiation-induced injury to the patient may be delayed.
Patients should be counseled on potential radiation side effects
and whom they should contact if they show symptoms.
• Pay careful attention for signs of non-targeted embolization. During
injection, carefully monitor patient's vital signs to include SaO
(e.g. hypoxia, CNS changes). Consider terminating the procedure,
investigating for possible shunting, or increasing EmboCube
Embolization Gelatin size if any signs of non-target embolization
occur or patient symptoms develop.
• Consider upsizing the EmboCube Embolization Gelatin if
angiographic evidence of embolization does not quickly appear
evident during injection of the EmboCube Embolization Gelatin.
• EmboCube Embolization Gelatin does not occlude vessels larger
than 5 mm. If target vessel is larger than 5 mm, consider using other
therapies.
• 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.
CAUTIONS
• DO NOT USE THIS PREFILLED SYRINGE TO DIRECTLY INJECT
EMBOCUBE EMBOLIZATION GELATIN. THIS IS A "RESERVOIR"
SYRINGE. Use of a 1mL or 3mL syringe provides more controlled
delivery and helps to avoid non-target embolization. PLEASE
REFER TO INSTRUCTIONS FOR USE PARAGRAPH.
• EmboCube Embolization gelatin must only be used by specialist
physicians trained in vascular embolization procedures. The size
and quantity of EmboCube Embolization Gelatin must be carefully
selected according to the lesion to be treated, entirely under the
physician's responsibility. Only the physician can decide the most
appropriate time to stop the injection of EmboCube Embolization
Gelatin.
• Do not use the EmboCube Embolization Gelatin if the syringe or
packaging appear damaged.
• For single patient use only – Contents supplied sterile - Never
reuse, reprocess or resterilize the contents of a syringe. Reusing,
reprocessing or resterilizing may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reusing, reprocessing
or resterilizing may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but
not limited to, the transmission of infectious disease(s) from one
patient to another. Contamination of the device may lead to injury,
illness or death of the patient. All procedures must be performed
according to accepted aseptic technique.
• There is no testing done on using EmboCube with agents such as
chemotherapies, sterile water, or lipiodol.
POTENTIAL COMPLICATIONS
Vascular embolization is a high risk procedure. Complications may occur
at any time during or after the procedure, and may include, but are not
limited to, the following:
• Stroke or cerebral infarction
• Occlusion of vessels in healthy territories
• Vascular rupture
• Neurological deficits
• Infection or haematoma at the injection site
• Allergic reaction, cutaneous irritations
• Transient pain and fever
• Vasospasm
• Death
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