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OptiCross
™
and OptiCross
6 HD
60 MHz Coronary
Imaging Catheters
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
WARNING
Contents supplied STERILE using a Radiation process. Do not
use if sterile barrier is damaged. If damage is found, call your
Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing
or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with
hospital, administrative and/or local government policy.
Carefully read all instructions prior to use. Observe all
contraindications, warnings, precautions and adverse events
noted in these directions. Failure to do so may result in patient
complications. Boston Scientific relies on the physician
to determine, assess and communicate to each patient all
foreseeable risks of the procedure.
DEVICE DESCRIPTION
OptiCross HD and OptiCross 6 HD (60 MHz Coronary Imaging
Catheters) are sterile, short rail imaging catheters. Available in
5F and 6F sizes.
They consist of two main assemblies:
1. Imaging Core
2. Catheter Body
The imaging core is composed of a hi-torque, flexible, rotating
drive cable with a radial looking 60 MHz ultrasonic transducer
at the distal tip. An electro-mechanical connector interface at
the proximal end of the catheter makes the connection to the
Motordrive Unit (MDU5 PLUS™) Instrument. The MDU5 PLUS-
catheter interface consists of an integrated mechanical drive
socket and electrical connection.
The catheter body is comprised of three sections:
1. Distal Imaging Window Lumen
2. Proximal Shaft Lumen
3. Telescoping Section
The distal imaging window lumen and proximal shaft lumen
sections comprise the "working length" of the catheter, and the
telescoping section remains outside of the guiding catheter.
The catheter body has a distal imaging window lumen with proximal
exit at 1.6 cm from the distal end (Figure 1). A radiopaque (RO)
marker is embedded in the catheter body at 0.5 cm from the distal
tip. In addition, two insertion depth markers are located on the
proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in
estimating catheter position relative to the distal guide catheter tip.
The proximal shaft lumen is attached to the telescoping section via
a strain relief connection.
The telescoping shaft (section) allows the imaging core to be
advanced and retracted for 15 cm of linear movement. The
corresponding movement of the transducer occurs from the
proximal end of the guidewire exit port to the proximal end of
the distal imaging window lumen. The telescope section has
proximal markers for lesion length assessment, consisting of a
series of marks spaced 1 cm apart on the telescope body.
A flush port with a one-way check valve (Figure 1) is used to
flush the interior of the catheter body and maintain a flushed
condition. The catheter must be flushed with heparinized saline
prior to use, as this provides the acoustic coupling media
required for ultrasonic imaging. The one-way check valve helps
retain saline in the catheter during use.
Black (K) ∆E ≤5.0
HD
Contents
OptiCross HD and OptiCross 6 HD (60 MHz Coronary Imaging
Catheters)
™
MDU5 PLUS Sterile Bag
17.78 cm (7 in) extension tube
3 cm³ (3 cc) and 10 cm³ (10 cc) syringes
4-way stopcock
INTENDED USE/INDICATIONS FOR USE
This catheter is intended for ultrasound examination of coronary
intravascular pathology only. Intravascular ultrasound imaging is
indicated in patients who are candidates for transluminal coronary
interventional procedures.
CONTRAINDICATIONS
Use of this imaging catheter is contraindicated where
introduction of any catheter would constitute a threat to patient
safety. The contraindications also include the following:
• Bacteremia or sepsis
• Major coagulation system abnormalities
• Patients diagnosed with coronary artery spasm
• Patients disqualified for CABG surgery
• Patients disqualified for PTCA
• Severe hemodynamic instability or shock
• Use of the imaging catheter to cross a total occlusion
WARNINGS
• Do not use device after indicated 'Use By' date. Use of an
expired device could result in patient injury due to device
degradation.
• Intravascular ultrasound examination of coronary anatomy
should be performed only by physicians fully trained in
interventional cardiology or interventional radiology and
in the techniques of intravascular ultrasound, and in the
specific approach to be used, in a fully-equipped cardiac
catheterization lab.
• The catheter has no user serviceable parts. Do not attempt
to repair or to alter any component of the catheter assembly
as provided. Using an altered catheter can result in poor
image quality or patient complications.
• No modification of this equipment is allowed.
• Air entrapped in the catheter and flushing accessories
can cause potential injury or death. Always verify that the
catheter and flushing accessories have been properly
cleared of air prior to inserting the catheter into the
vasculature.
• Do not pinch, crush, kink or sharply bend the catheter at
any time. This can cause poor catheter performance, vessel
injury or patient complications. An insertion angle greater
than 45° is considered excessive.
• Never advance or withdraw the imaging catheter without
fluoroscopic visualization because it may cause vessel
injury or patient complications.
• Do not advance the catheter if resistance is encountered. The
catheter should never be forcibly inserted into lumens narrower
than the catheter body or forced through a tight stenosis. A
catheter that is forcibly advanced may cause catheter damage
resulting in vessel injury or patient complications.
• When advancing the catheter through a stented vessel,
catheters that do not completely encapsulate the guidewire
may engage the stent between the junction of the catheter
and guidewire, resulting in entrapment of catheter/
guidewire, catheter tip separation, and/or stent dislocation.
• If resistance is met upon withdrawal of the catheter, verify
resistance using fluoroscopy, then remove the entire system
simultaneously. A catheter that is forcibly removed may
cause vessel injury or patient complications.
• When readvancing a catheter after deployment of stent(s),
at no time should a catheter be advanced across a
guidewire that may be passing between one or more stent
struts. A guidewire may exit between one or more stent
struts when recrossing stent(s). Subsequent advancement
of the catheter could cause entanglement between the
catheter and the stent(s), resulting in entrapment of
catheter/guidewire, catheter tip separation and/or stent
dislocation. Use caution when removing the catheter from a
stented vessel.
• Inadequately apposed stents, overlapping stents, and/or
small stented vessels with distal angulation may lead to
entrapment of the catheter with the stent upon retraction.
When retracting the catheter, separation of a guidewire from
an imaging catheter or bending of the guidewire may result
in kinking of the guidewire, damage to the catheter distal tip,
and/or vessel injury. The looped guidewire or damaged tip
may catch on the stent strut resulting in entrapment.
• If multiple insertions are required, the catheter should not be
disconnected from the MDU5 PLUS to avoid possible breach
of catheter sterility.
PRECAUTIONS
• Do not attempt to connect the catheter to electronic
equipment other than the designated Systems because the
catheter may not function properly.
• Never attempt to attach or detach the catheter while the
motor is running. To do so may damage the connector.
• If difficulty is encountered when backloading the guidewire
into the distal end of the catheter, inspect the guidewire
exit port for damage before inserting the catheter into the
vasculature. The use of a damaged guidewire exit port
could increase the resistance of catheter advancement or
withdrawal.
• Never advance the imaging catheter without guidewire
support because it can cause difficulty in reaching the
intended region of interest or can cause the distal catheter
tip to kink.
• Never advance the distal tip of the imaging catheter near the
very floppy end of the guidewire. This part of the guidewire
will not adequately support the catheter. A catheter
advanced to this position may not follow the guidewire when
it is retracted and cause the guidewire to buckle into a loop
which the catheter may drag along the inside of the vessel
and catch on the guide catheter tip. If this occurs, it may be
necessary to remove the catheter assembly, guidewire and
the guide catheter together. If the catheter is advanced too
near the end of the guidewire, advance the guidewire while
holding the imaging catheter steady. If this fails, withdraw the
catheter and guidewire together.
• Never advance or withdraw the imaging catheter without
the imaging core assembly being positioned at the most
distal position of the imaging window because it may cause
the catheter to kink.
• During and after the procedure, inspect the catheter
carefully for any damage which may have occurred during
use. Multiple insertions may lead to catheter exit port
dimension change/distortion which could increase the
chance of the catheter catching on the stent. Care should
be taken when re-inserting and/or retracting catheter to
prevent exit port damage.
• Always turn the MDU5 PLUS "OFF" before withdrawing the
imaging catheter because it could cause the motor drive
to overload.
ADVERSE EVENTS
The risks and discomforts involved in vascular imaging include
those associated with all catheterization procedures. These risks
or discomforts may occur at any time with varying frequency
or severity. Additionally, these complications may necessitate
additional medical treatment including surgical intervention and,
in rare instances, result in death.
• Allergic reaction
• Angina
• Cardiac arrest
• Cardiac arrhythmias including, but not limited to ventricular
tachycardia, atrial/ventricular fibrillation and complete
heart block
• Cardiac tamponade/Pericardial effusion
• Death
• Device entrapment requiring surgical intervention
• Embolism (air, foreign body, tissue or thrombus)
• Hemorrhage/Hematoma
• Hypotension
• Infection
• Myocardial infarction
• Myocardial Ischemia
• Stroke and Transient Ischemic Attack
• Thrombosis
• Vessel occlusion and abrupt closure
• Vessel trauma including, but not limited to dissection
and perforation
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