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LBL 61361 Rev C, Instruction for Use (May 2018)
EN
Warnings
1. This device is intended for single (one) time use only.
DO NOT re-sterilize and/or reuse.
2. Do not use a device past the expiration date on the
label. Use of expired product may result in patient injury.
3. Percutaneous transluminal IVL should only be
performed at hospitals with adequate emergency
surgical support.
4. Inspect all product components and packaging prior to
use. Do not use the device if the device or the packaging
has been damaged or if sterility has been compromised.
Damaged product could result in patient injury.
5. Do not use the device if the balloon protective sheath
cannot be removed easily prior to use. If excessive force
is used the catheter could be damaged. Damaged
product could result in patient injury.
6. For preparation, operation, warnings and precautions,
and maintenance of the IVL Generator and its accessories
refer to the IVL Generator Operator’s Manual.
7. IVL Connector Cable is non-sterile and must be
enclosed in a sterile sleeve prior to and during use.
8. Use only an appropriately sized balloon for the vessel
to be treated.
9. Inflate the balloon according to the balloon compliance
chart. Balloon pressure should not exceed the rated
burst pressure (RBP).
10. Perform all device manipulations under adequate
fluoroscopic guidance.
11. Do not advance or retract the catheter unless the
balloon is fully deflated under vacuum. If resistance is
met during manipulation, determine the cause of the
resistance before proceeding.
12. Do not use, or attempt to straighten, a catheter if the
shaft has become bent or kinked. Instead, prepare
a new catheter.
13. Do not use excessive force or torque on the catheter as
this could result in damage to the device components
and result in patient injury.
14. Use only one (1) catheter of any given size. If a second
catheter of the same size is necessary, DO NOT re-use
the first catheter. Discard it before preparing the
second catheter.
15. This device should only be used by physicians trained in
angiography and intravascular coronary procedures.
16. Physicians must read and understand these instructions
prior to use of the device.
17. Treat patients per standard medication or interventional
procedures in the event of complications associated
with the procedure or device.
Precautions
1. Use only the recommended 50/50 contrast/saline
balloon inflation medium.
2. During the procedure, appropriate anticoagulant
therapy must be provided to the patient as needed.
Anticoagulant therapy should be continued for
a period of time to be determined by the physician
after the procedure.
3. Inflate the balloon according to the compliance chart.
DO NOT overinflate balloon as this may cause
patient injury.
4. Use the IVL Generator in accordance with recommended
settings as stated in the IVL Generator Operator’s
Manual. DO NOT deviate from recommended settings
as this may cause patient injury.
5. If an inability to inflate or maintain balloon pressure
occurs, remove the catheter and use a new device.
6. If the IVL Catheter appears not to deliver lithotripsy
therapy, remove and replace it with another catheter.
7. Ensure that the IVL Catheter is used with a 0.014"
guidewire and is inserted through a 6F guiding
catheter at least 0.068" (1.72mm) ID. Failure to do
so could result in inadequate device performance
or patient injury.
8. Precaution should be taken when handling device after
exposure to patient, e.g. contact with blood. Used
product is considered biohazardous material and
should be disposed of properly as per hospital
protocol.
9. Precaution should be taken when treating patients with
previous stenting within 5mm of target lesion.
Adverse Effects
Possible adverse effects are consistent with standard
catheter-based cardiac interventions and include,
but are not limited to, the following:
• Abrupt vessel closure
• Access site pain
• Allergic reaction to contrast medium, anticoagulant
and/or antithrombotic therapy
• Arrhythmia
• Arteriovenous fistula
• Bleeding complications
• Cardiac tamponade or pericardial effusion
• Coronary artery occlusion, perforation, rupture
or dissection
• Coronary artery spasm
• Death
• Emboli (air, tissue, thrombus or atherosclerotic emboli)
• Emergency or non-emergency coronary artery
bypass surgery
• Emergency or non-emergency percutaneous coronary
intervention
• Entry site complications
• Fracture of the guide wire or any component of the
device that may or may not lead to device embolism,
serious injury or surgical intervention
• Hematoma at the vascular access site(s)
• Hemorrhage
• Hypertension/Hypotension
• Infection/sepsis
• Myocardial Infarction
• Myocardial Ischemia or unstable angina
• Peripheral Ischemia
• Pseudoaneurysm
• Renal failure/insufficiency
• Restenosis of the treated coronary artery
• Shock/pulmonary edema
• Stroke
• Vascular complications which may require surgical repair
(conversion to open surgery)
In addition, patients may be exposed to other risks
associated with coronary interventional procedures,
including risks from conscious sedation and local
anesthetic, the radiographic contrast agents used during
angiography, the drugs given to manage the subject
during the procedure, and the radiation exposure from
fluoroscopy.
Risks identified as unique to the device and its use:
• Allergic/immunologic reaction to the catheter material(s)
or coating
• Device malfunction or failure
• Excess heat at target site
• Premature ventricular contraction
Procedural Steps
Caution:
Refer to the IVL Generator and IVL Connector
Cable Operator’s Manual for preparation, operation,
warnings and precautions, and maintenance of the
IVL Generator and IVL Connector Cable.
Preparation
1. Prepare the insertion site using standard sterile
technique.
2. Achieve preferred vascular access and place
a guidewire and guide catheter.
3. Select a lithotripsy balloon catheter size that is 1:1
based on balloon compliance chart (above) and
reference vessel diameter.
4. Remove the IVL Catheter from the package.
5. Prepare the lithotripsy balloon using standard
technique. Fill a 20cc syringe with 5cc of 50/50 saline/
contrast medium. Attach syringe to inflation port on
catheter hub. Pull vacuum at least 3 times, releasing
vacuum to allow the fluid to replace the air in
the catheter.
6. Fill indeflator device with 10cc of 50/50 saline/contrast
medium. Disconnect syringe and connect indeflator
to inflation port of catheter hub ensuring no air
is introduced to the system.
7. Remove the protective sheath and shipping mandrel
from the IVL Catheter.
Warning:
Do not use the device
if the protective sheath or shipping mandrel are difficult
to remove or cannot be removed.
8. Flush the guidewire port with saline.
9. Wet the lithotripsy balloon and distal shaft with sterile
saline in order to activate the hydrophilic coating.
10. Insert the IVL Connector Cable into the sterile sleeve
or probe cover.
