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ENGLISH
RETRACTA™ DETACHABLE 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
The Retracta Detachable Embolization Coil is a platinum coil with spaced
synthetic fibers, and is attached to a delivery wire. (Figs. 1 & 2) The Retracta
Detachable Embolization Coil is designed to be delivered under fluoroscopy
to the target vessel. The Retracta Detachable Embolization Coil system
allows the coil to be advanced and fully repositioned before the coil is finally
deployed.
INTENDED USE
The Retracta Detachable Embolization Coil is intended for arterial and venous
embolization in the peripheral vasculature. The coil delivery system provides
safe delivery of embolization coils when correct positioning is especially
critical.
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.
• The Retracta Detachable Embolization Coil is not recommended for use
with polyurethane catheters or catheters with sideports. If a catheter
with sideports is used, the embolus may lodge in the sideport or pass
inadvertently through it. Use of a polyurethane catheter may also result in
lodging of the embolus within the catheter.
PRECAUTIONS
• Perform an angiogram prior to embolization to determine correct catheter
position.
• Prior to introduction of the embolization coil, flush the angiographic
catheter with saline.
• This product is intended for use by physicians trained and experienced in
arterial and venous vessel embolization techniques. Standard techniques
for placement of vascular access sheaths, angiographic catheters, and wire
guides should be employed.
PRODUCT RECOMMENDATIONS
The following catheters are recommended for use with Retracta Detachable
Embolization Coil:
• HNB(R)4.0-35
• HNB(R)5.0-35
• HNB(R)5.0-38
• SCBR-5.0-38
• SCBR-4.0-38
The PTBYC-RA is recommended for use with the Retracta Detachable
Embolization Coil to perform a test injection of contrast media.
MRI INFORMATION
Nonclinical testing has demonstrated that the Retracta Detachable
Embolization Coil is MR Conditional according to ASTM F2503. A patient with
this coil can be scanned safely after placement under the following conditions.
• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption
rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning
or less (i.e., per scanning sequence)
Static Magnetic Field
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
In nonclinical testing, the Retracta Detachable Embolization Coil produced a
maximum temperature rise of 1.1 °C (scaled to an SAR of 2.0 W/kg) during 15
minutes of MR imaging (i.e., for one scanning sequence) performed in a MR
3.0 Tesla System (General Electric Excite, HDx, Software 14X.M5).
Image Artifact
MR image quality may be compromised if the area of interest is within
approximately 9 mm of the position of the Retracta Detachable Embolization
Coil, as found during non clinical testing using the sequence: T1-weighted,
