vascular solutions GuideLiner 5570 5.5F Gebrauchsanweisung

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©2012 Vascular Solutions, Inc.
®
GuideLiner Catheter
Instructions For Use
USA CAUTION
Federal law restricts this device to sale by or on the
order of a physician.
DEVICE DESCRIPTION
The GuideLiner catheter is a single lumen rapid
exchange catheter offered in sizes compatible with 6F,
7F, and 8F guide catheters and may be placed over an
exchange length or 180cm guidewire. The larger sizes
of GuideLiner catheters are intended to be used within
the proximal portions of the coronary vasculature to
provide support and/or facilitate use of multiple
interventional devices. The 150cm device has a
stainless steel shaft with a 25cm single lumen wiped
with silicone.
The GuideLiner catheter has two platinum-iridium
marker bands, which enable visibility while using
standard fluoroscopic methods. The distal marker
band is located 0.085" / 2.16mm from the distal tip. The
proximal marker band is located 1cm from the collar.
The device has two positioning marks located at 95cm
(single mark) and 105cm (double mark) from the distal
tip, respectively.
The GuideLiner catheter is delivered through a guide
catheter resulting in an inner diameter that is
approximately 1 French smaller than the guide
catheter. The GuideLiner catheter has a proximal tab
which indicates guide catheter compatibility and the
resulting GuideLiner catheter inner diameter.
The GuideLiner catheter has been sterilized with ethylene
oxide.
SPECIFICATIONS
Compatible GuideLiner
Guide Min. I.D.
Model
Catheter
5570 ≥ 6F (≥ 0.066" 0.051" /
5.5F / 1.68mm I.D.) 1.30mm
5571 ≥ 6F (≥ 0.070" 0.056" /
6F / 1.78mm I.D.) 1.42mm
≥ 7F (≥
5572 0.062" /
0.078"/
7F 1.57mm
1.98mm I.D.)
5573 ≥ 8F (≥ 0.088" 0.071" /
8F / 2.24mm I.D.) 1.80mm
INDICATIONS
GuideLiner catheters are intended to be used in
conjunction with guide catheters to access discrete regions
of the coronary and/or peripheral vasculature, and to
facilitate placement and exchange of guidewires and other
interventional devices.
CONTRAINDICATIONS
The GuideLiner catheters are contraindicated in vessels
less than 2.5mm in diameter, vessels in the
neurovasculature and the venous system.
WARNINGS
The GuideLiner catheter is provided sterile for single use
only. Reuse of single-use device creates a potential risk of
patient or user infections. Contamination of the device may
lead to illness or serious patient injury
Never advance the GuideLiner catheter into a vessel
without a leading guidewire or without confirming location
using fluoroscopic guidance. Vessel dissection or
perforation may result.
Never advance the GuideLiner catheter into a vessel with
an effective diameter less than 2.5mm. Vessel injury,
ischemia, and/or occlusion may result. If pressure in a
vessel dampens after inserting the GuideLiner catheter,
withdraw the GuideLiner catheter until the pressure returns
to normal.
Due to the size and non-tapered tip of the GuideLiner,
extreme care must be taken to avoid vessel occlusion and
1
damage to the wall of the vessels through which this
catheter passes.
Never advance or withdraw an intravascular device against
resistance until the cause of the resistance is determined
by fluoroscopy. Movement of the catheter or guidewire
against resistance may result in separation of the catheter
or guidewire tip, damage to the catheter, or vessel
perforation.
PRECAUTIONS
Do not use the GuideLiner catheter if the packaging has
been damaged.
Inspect the GuideLiner catheter prior to use for any bends
or kinks. Do not use a damaged catheter. Vessel damage
and/or inability to advance or withdraw the catheter may
occur.
The catheter lumen should be thoroughly flushed with
heparinized saline prior to use to prevent clot formation.
The GuideLiner catheter deployment procedure should be
performed by physicians thoroughly trained in
percutaneous, intravascular techniques and procedures.
Precautions to prevent or reduce clotting should be taken
when any catheter is used in the vascular system. Use of
systemic heparinization and heparinized sterile solution
should be considered.
Exercise care in handling of the catheter during a
procedure to reduce the possibility of accidental breakage,
bending or kinking.
When the catheter is in the body, it should be manipulated
only under fluoroscopy. Do not attempt to move the
catheter without observing the resultant tip response.
Never advance the GuideLiner catheter more than 15cm
beyond the tip of the guide catheter as the GuideLiner
catheter may become lodged in the guide catheter making
it difficult to remove.
COMPLICATIONS
The following complications are generally associated with
GuideLiner
catheterization procedures and may occur when using the
Tip O.D.
GuideLiner catheter:

local or systemic infection
0.063" /
1.60mm

air embolism
0.067" /

intimal disruption
1.70mm

arterial dissection
0.075" /

1.90mm perforation of the vessel wall

vascular occlusion
0.085" /
2.16mm

arterial thrombosis

myocardial infarction

arterial spasm
CLINICAL PROCEDURE
The GuideLiner catheter should be used by physicians
trained on the procedures for which the device is intended.
The techniques and procedures described do not
represent ALL medically acceptable protocols, nor are they
intended as a substitute for the physician's experience and
judgment in treating any specific patient. All available data,
including the patient's signs and symptoms and other
diagnostic test results, should be considered before
determining a specific treatment plan.
Package contains:

Single-use disposable GuideLiner catheter
Other items required but not provided:

Guide catheter with an inner diameter large enough
to accommodate the specific model of GuideLiner
catheter in use

Y-adaptor with hemostasis valve (Tuohy-Borst type)

Guidewire with diameter ≤ 0.014" / 0.36mm

Sterile syringe (for system flushing)

Sterile heparinized saline (for system flushing)
PREPARATIONS FOR USE
1. Prior to use, carefully inspect the GuideLiner catheter
packaging and components for damage.
2. Using sterile technique, transfer the dispenser coil
with the GuideLiner catheter into the sterile field.
3. Thoroughly flush the lumen of the GuideLiner
catheter from the distal tip with heparinized saline
solution.
42-0773-01 Rev F 03/12