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1.
DESCRIPTION........................................................................................................................................................................................................................3
2.
INDICATIONS FOR USE.........................................................................................................................................................................................................3
3.
SPECIFICATIONS...................................................................................................................................................................................................................3
4.
CONTRAINDICATIONS..........................................................................................................................................................................................................3
5.
WARNINGS.............................................................................................................................................................................................................................3
6.
PRECAUTIONS.......................................................................................................................................................................................................................3
7.
ADVERSE EVENTS..................................................................................................................................................................................................................4
8.
HOW SUPPLIED.....................................................................................................................................................................................................................4
9.
COMPATIBILITY......................................................................................................................................................................................................................4
10.
DIRECTIONS FOR USE............................................................................................................................................................................................................4
11.
WARRANTY INFORMATION..................................................................................................................................................................................................4
12.
NON-STANDARD SYMBOLS..................................................................................................................................................................................................4
1.
DESCRIPTION
The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in 9 models. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating
geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The distal
40 cm of each catheter model is coated with a lubricious, hydrophilic coating.
Model number 518-032 and 518-065 has a shaft of varying sti ness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 2.0 Fr and is compatible with a 0.014 inch or smaller guidewire.
Model numbers 518-033, 518-034, and 518-035 have a shaft of varying sti ness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.3 Fr and are compatible with a 0.018 inch
or smaller guidewire.
Model numbers 518-036, 518-037, 518-038, and 518-066 have a shaft of varying sti ness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.8 Fr and are compatible
with a 0.035 inch or smaller guidewire.
2.
INDICATIONS FOR USE
The Spectranetics Quick-Cross Support Catheters are guide wire exchange and infusion devices designed for use in the vascular system. The catheters are intended to support a guidewire during access
of vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
3.
SPECIFICATIONS
GW Compatibility, inch
Working Length, cm
Minimum guidewire length, cm
Distal marker spacing, mm
Outer Diameter (O.D.), inch
Distal Shaft diameter, inch
Tip Pro le, inch
Minimum Guide Catheter, Fr.
Sheath Compatibility, Fr.
4.
CONTRAINDICATIONS
No known contraindications
5.
WARNINGS
•
This catheter should only be used by physicians quali ed to perform percutaneous, vascular interventions.
•
Catheter manipulation should only occur under uoroscopy.
•
The catheter should not be advanced through an area of resistance unless the source of resistance is identi ed by uoroscopy and appropriate steps are taken to reduce or remove the obstruction.
•
The catheter should not be advanced into a vessel having a diameter smaller than the catheter outer diameter.
6.
PRECAUTIONS
•
DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination due to inappropriate reprocessing. Reuse of this single use
device could lead to serious patient injury or death and voids manufacturer warranties.
•
Maximum infusion pressure is 300 psi.
•
The catheter is designed and intended for intravascular use only.
•
This catheter is designed and intended for one time use only.
•
Careful inspection before use should verify that the catheter has not been damaged in shipment and that its condition is suitable for the procedure.
•
Only use guidewires of the recommended diameter and length.
•
If the catheter is used for infusion, reference the table of ow rates and ensure infusion pressure does not exceed the recommendations.
•
Avoid introducing air or any other gas through the catheter into the vascular system.
P001260-09
07Jan19
Quick-Cross® Support Catheter
Table of Contents
Luer
Distal Marker Pacing
518-032
518-065
518-033
0.014
0.014
135
150
180
180
15
15
0.039
0.039
0.026
0.026
0.020
0.020
5
5
4
4
(2019-01-07)
Working Length
Distal Marker Pacing
Distal Section
518-034
518-035
0.018
0.018
0.018
90
135
150
150
180
180
15
15
15
0.044
0.044
0.044
0.030
0.030
0.030
0.023
0.023
0.023
5
5
5
4
4
4
Instructions for Use
English / English
3 mm
518-066
518-036
518-037
0.035
0.035
0.035
65
90
135
150
150
180
50
50
50
0.063
0.063
0.063
0.050
0.050
0.050
0.041
0.041
0.041
6
6
6
5
5
5
518-038
0.035
150
180
50
0.063
0.050
0.041
6
5
3
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