Codman ORBIT GALAXY G2 Información Importante página 2

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
®
ORBIT GALAXY G2 Microcoil Delivery System
® ®
XTRASOFT ORBIT GALAXY G2 Microcoil
SYSTEM DESCRIPTION
The ORBIT GALAXY G2 Microcoil Delivery System consists of three components, a Microcoil
System, a connecting cable, and a Detachment Control Box (DCB). Each component is
sold separately.
As shown in Figure 1, the Microcoil System consists of an embolic microcoil attached to a device
positioning unit (DPU) wire. It is covered by an introducer sheath system. The microcoil's shape can
be complex or helical. The DPU wire is a variable stiffness pushing system and has a radiopaque
marker band located three (3) cm from its distal end. The introducer sheath system has three main
components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
hub connector re-sheathing tool
device positioning unit (DPU)
Fig. 1: Microcoil System
The connecting cable delivers the energy needed to detach the coil from the Microcoil
System's detachment zone. The connecting cable is connected between the Microcoil
System's hub connector on the DPU Wire and the output connector on the DCB. Its length
is approximately 5–6 ft (1.5–1.8 m). The connecting cable may be one of two types: one with
a remote detach button (the EnPOWER ® Control Cable) catalog no. ECB000182-00, or one
without a detach button catalog no. CCB000157-00 (the standard connecting cable).
The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-
mechanical detachment of the microcoil from the DPU wire. The blue EnPOWER Detachment
Control Box works with the EnPOWER Control Cable or with the standard connecting cable.
Both cables are available separately from the microcoil delivery system.
INDICATIONS FOR USE
The XTRASOFT ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular
embolization of intracranial aneurysms.
WARNINGS
• The ORBIT GALAXY G2 Microcoil Delivery System should only be used as a complete system.
A complete system requires a Detachment Control Box, a connecting cable, and Microcoil
System. DO NOT SUBSTITUTE any components or devices from other manufacturers with
the Codman Detachment Control Box or injury to the patient or user could result.
• Explosion Hazard: The Detachment Control Box is not suitable for use in the
presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide
or oxygen enriched atmospheres.
PRECAUTIONS
The Microcoil System shall be used only by physicians trained in interventional neuroradiology
and in all aspects of the system.
Do not attempt to sterilize any component of the Microcoil Delivery System.
The Detachment Control Box (DCB) is provided NON-STERILE. Unless placed in a sterile
sleeve, it should remain outside of the sterile field during use. The DCB is the only reusable
portion of the Microcoil Delivery System. Upon receipt of the DCB, inspect the shipping
carton and the unit for signs of damage. If unit presents with physical damage upon shipment,
immediately notify Codman & Shurtleff, Inc. for replacement.
Verify the functionality of the Microcoil Delivery System before proceeding with microcoil
placement. Refer to the section Microcoil System Preparation on how to verify the functionality.
ADVERSE EVENTS
Possible adverse events include, but are not limited to, the following: hematoma at site of
entry, vessel perforation, infection, emboli, hemorrhage, ischemia or vasospasm, neurological
deficits including stroke, and possibly death.
introducer
introducer
sheath tip
sheath
body
microcoil
2
HOW SUPPLIED
The ORBIT GALAXY G2 Microcoil System and cables are intended for SINGLE
USE ONLY; DO NOT RESTERILIZE. Discard the Connecting Cable after one
procedure. Structural integrity and/or function may be impaired through reuse
or cleaning. Cables are extremely difficult to clean after exposure to biological
materials and may cause adverse patient reactions if reused.
Microcoils are permanent implants and are NOT reusable. Discard the microcoil
system if it is retrieved from the patient without being implanted. Structural
integrity and/or function may be impaired through reuse or cleaning. Microcoils are
extremely difficult to clean after exposure to biological materials and may cause
adverse patient reactions if reused.
Codman & Shurtleff will not be responsible for any product that is resterilized, nor
accept for credit or exchange any product that has been opened but not used.
As long as the inner unit is not opened or damaged, the Microcoil System and
Connecting Cable are sterile. The Microcoil System is nonpyrogenic.
REQUIRED ADDITIONAL MATERIALS
The following items are either supplied with the system or sold separately and
must be on-hand prior to commencing a procedure.
• Femoral sheath
• Guiding catheter, 5 to 7 Fr
• Infusion microcatheter with 2 tip markers located 3 cm apart
• Guidewire compatible with the selected infusion microcatheter
• Three (3) continuous saline (or heparinized saline) flush set-ups with pressure
bags: one (1) flush system for the femoral sheath, one (1) for the guiding
catheter, and one (1) for the microcatheter
• Two (2) rotating hemostatic valves (RHV)
• Three-way stopcock
• One-way stopcock
• IV Pole (not required if DCB will be placed in sterile sleeve and placed in
sterile field)
Note: A backup Codman Detachment Control Box is suggested for all procedures.
INSTRUCTIONS
MICROCOIL SIZE SELECTION
Microcoil selection is at the discretion of the physician. The appropriate microcoil
size should be chosen based upon pre-embolization angiographic assessment
of the diameter, height, and width of the aneurysm, as well as, the width of
the aneurysm ostium. In most cases, the initial microcoil implanted should be
a three-dimensional complex shape. To minimize the potential of microcoil
migration away from the aneurysm, the diameter of the first microcoil selected
should not be less than the width of the aneurysm neck ostium. The subsequent
selected coils typically will be of decreasing size and the physician may continue
to implant microcoils until he or she determines that the aneurysm has been
successfully treated.
MICROCATHETER SELECTION
Proper selection of the appropriately sized microcatheter is required to avoid
damage to the Microcoil System and to minimize potential complications.
Microcatheter selection is also determined by the physician and is predicated by
the location of the aneurysm, patient safety, and physician preference. To ensure
proper placement and detachment of the Microcoil, the selected microcatheter
must have two (2) radiopaque tip markers three (3) cm apart.
The XTRASOFT ORBIT GALAXY G2 System is compatible with microcatheters
with inner lumen diameters ranging from 0.0165 to 0.019 in. (0.419 to 0.483 mm).
CONTINUOUS SALINE FLUSH SET-UP
To achieve optimal performance of the Microcoil System, it is important that
a continuous infusion of an appropriate flush solution be maintained. Figure 2
illustrates the connections necessary for the Microcoil Delivery System including a
typical continuous saline flush set-up with pressure bag for the catheter systems.
1. Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter.
2. Connect a three-way stopcock to the RHV sidearm, and attach a line to the
stopcock for the continuous infusion of solution.
3. Carefully select an appropriately sized infusion microcatheter based on the
size of the selected Microcoil System.
4. Insert the infusion microcatheter into the RHV connected to the guiding
catheter hub.
5. Attach a second RHV to the hub of the infusion microcatheter.
6. Connect a one-way valve stopcock to the RHV's sidearm, and attach a flush line.
7. Adjust the hydrostatic pressure to 300 mm of Hg and maintain an open flush
throughout the procedure.