GORE Tri-Lobe Mode D'emploi page 3

INSTRUCTIONS FOR USE FOR
GORE® Tri-Lobe Balloon Catheter
CAUTION: USA Federal Law restricts the sale, distribution, or use of this device to, by, or on the order of a physician.
Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions.
Failure to do so may result in complications.
DESCRIPTION
The GORE® Tri-Lobe Balloon Catheter (balloon catheter) (Figure 1) is a compliant, tri-lobed polyurethane balloon catheter. The
lobed design of the balloon catheter allows for inflation without complete blockage of aortic blood flow (see Figure 2 for balloon
inflation volume). The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque
markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The
inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows
introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is
affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated
into the trailing end of the guidewire lumen.
The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon (BCM1634) can be inflated to diameters of
16 mm to 34 mm and the larger balloon (BCL2645) can be inflated to diameters of 26 mm to 42 mm (Figure 2). Both balloon
sizes are 18 Fr sheath compatible.
FIGURE 1: GORE® TRI-LOBE BALLOON CATHETER
0.035" (0.89 mm) Guidewire Compatibility
Radiopaque
Tip
Radiopaque Marker Bands
FIGURE 2: GORE® TRI-LOBE BALLOON CATHETER INFLATION VOLUME GUIDE
35
30
25
20
15
10
5
0
15
INTENDED USE
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter
vessels.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
• Excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death.
• Do not continue if resistance is felt during advancement or retraction of the balloon catheter. Stop and assess the cause of
the resistance. Continued movement against resistance may result in prosthesis migration, vessel damage, and / or catheter
damage.
• Do not advance or retract the balloon catheter while the balloons are inflated. Ensure the balloons are deflated using
fluoroscopy before moving the balloon catheter.
108 cm
104 cm
18 Fr Sheath
Compatibility
Three Balloons (shown inflated)
20 25
Intended Balloon Diameter (mm)
BCM1634
Flushing / Guidewire Port with Luer Lock
Multi-Lumen
Catheter Shaft Tuohy-Borst Valve
30 35
BCL2645
1
Inflation Port
with Luer Lock
Integrated
40 45