Mri Information - COOK Medical MReye Instrucciones De Uso

ENGLISH
MREYE® EMBOLIZATION COIL
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
MReye Embolization Coils are made of Inconel, an MR conditional super
alloy with spaced synthetic fibers and are supplied preloaded in a loading
cartridge. They are designed to be delivered to the target vessel using a soft,
straight wire guide through a standard angiographic catheter.
INTENDED USE/INDICATIONS FOR USE
MReye Embolization Coils are intended for use in peripheral arterial and
venous vessel embolization procedures.

MRI INFORMATION

Nonclinical testing has demonstrated that single and multiple MReye®
Embolization Coils are MR Conditional according to ASTM F2503. A patient
with this device may be safely scanned after placement under the following
conditions.
• Static magnetic field of 3.0 tesla or 1.5 tesla only
• Maximum magnetic field spatial gradient of 1600 gauss/cm (16 T/m) or less
• Maximum MR system reported, whole-body-averaged specific absorption
rate (SAR) of ≤ 2.0 W/kg (Normal Operating Mode)
Under the scan conditions provided above, the MReye® Embolization Coil
is not expected to result in a temperature rise of more than 3.1°C after 15
minutes of continuous scanning.
The image artifact extends approximately 12 mm from the MReye®
Embolization Coil as found during nonclinical testing when imaged with a
gradient echo pulse sequence and a 3.0 Tesla MRI system.
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners:
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382, USA
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
CONTRAINDICATIONS
None known
WARNINGS
• Positioning of embolization coils should be done with particular care.
Coils should not be left too close to the inlets of arteries and should
be intermeshed with previously placed coils if possible. A minimal but
sufficient arterial blood flow should remain to hold the coils against the
previously placed coils until a solid clot ensures permanent fixation. The
purpose of these suggestions is to minimize the possibility of loose coils
becoming dislodged and obstructing a normal and essential arterial
channel.
• MReye Embolization Coils are not intended for neurovascular use.
• MReye Embolization Coils are not recommended for use with polyurethane
catheters or catheters with sideports. If a catheter with sideports is used,
the embolization coil may lodge in the sideport or pass inadvertently
through it. Use of a polyurethane catheter may also result in lodging of the
embolization coil within the catheter.
• If difficulties occur when deploying the embolization coil, withdraw the
wire guide, coil and angiographic catheter simultaneously as a unit.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced
in embolization techniques. Standard techniques for placement of
vascular access sheaths, angiographic catheters and wire guides should
be employed.
• Perform an angiogram prior to embolization to determine correct catheter
position.
• Prior to introduction of the embolization coil, flush the angiographic
catheter with saline.
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