Shockwave M5 - Page 3

Page 3 of 44LBL 61928 Rev B, Instructions for Use EU (February 2018) EN
Contraindications for Use
The IVL System is contraindicated for the following:
1. Unable to pass 0.014” guidewire across the lesion.
2. This device is not intended for treatment of in-stent
restenosis.
3. This device is not intended for use in coronary, carotid,
or cerebrovascular arteries.
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. Always insert the IVL Connector Cable into a sterile
sleeve prior to use.
4. Use only an appropriately sized balloon for the vessel
to be treated.
5. Inate the balloon according to the balloon compliance
chart. Balloon pressure should not exceed the rated
burst pressure (RBP).
6. Do not advance or retract the catheter unless the
balloon is fully deated under vacuum. If resistance is
met during manipulation, determine the cause of the
resistance before proceeding.
7. Use the IVL Generator in accordance with
recommended settings as stated in the Operator’s
Manual. Do not attempt to override the lifetime pulse
limits per device as dened in the IVL System Sequence
Chart.
8. This device should only be used by physicians who are
familiar with interventional vascular procedures.
9. Physicians must read and understand these instructions
prior to use of the device.
10. Do not use excessive force/torque when using this
device as this could result in damage to the device
components and patient injury.
11. Inspect all product components and packaging prior
to use. Do not use the device if it or the packaging has
been damaged or if sterility has been compromised.
Damaged product could result in patient injury.
12. For preparation, operation, warnings and precautions,
and maintenance of the IVL Generator and its
accessories refer to the IVL Generator and Connector Cable
Operator’s Manual.
Precautions
1. Perform all device manipulations under adequate
uoroscopic guidance.
2. Use only the recommended balloon ination medium.
3. Appropriate anticoagulant therapy should be
administered by the physician.
4. Decision regarding use of distal protection should be
made based on physician assessment of treatment
lesion morphology.
5. Care should be taken not to kink the catheter. If kinking
occurs, remove device and prepare a new device.
6. If an inability to inate or maintain pressure occurs,
remove the catheter and use a new device.
7. If the catheter appears not to deliver lithotripsy
pulsatile mechanical energy, remove and replace it with
another catheter.
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.
Adverse Eects
Possible adverse eects are consistent with standard
angioplasty and include:
• Access site pain
• Allergic reaction to contrast medium, anticoagulant and/
or antithrombotic therapy
• Arterial dissection
• Arterial perforation or rupture
• Arterial spasm
• Arteriovenous stula
• Bleeding complications
• Death
• Emboli (air, tissue, thrombus or atherosclerotic emboli)
• Emergency or non-emergency arterial bypass surgery
• 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
• Ischemia
• Placement of a stent
• Pseudoaneurysm
• Renal failure
• Restenosis of the treated segment
• Shock/pulmonary edema
• Total occlusion of the peripheral artery
• Vascular complications which may require surgical repair
(conversion to open surgery)
Risks identied as unique to the device and its use:
• Allergic/immunologic reaction to the catheter material(s)
• Device malfunction or failure
• Excess heat at target site due to malfunction of IVL
Generator
Procedural Steps
Caution: Refer to the IVL Generator and 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 vascular access and place an introducer sheath.
3. Select a balloon catheter size that is 1.1:1 based on
balloon compliance chart (above) and reference vessel
diameter.
4. Remove the IVL Catheter from the package.
5. Prepare the balloon using standard technique. Fill a
20cc syringe with 5cc of 50/50 saline/contrast medium.
Attach syringe to ination port on catheter hub. Pull
vacuum at least 3 times, releasing vacuum to allow the
uid to replace the air in the catheter.
6. Fill indeator device with 10cc of 50/50 saline/contrast
medium. Disconnect syringe and connect indeator
to ination port of catheter hub ensuring no air is
introduced to the system.
7. Flush the guidewire port with saline.
8. Remove the protection sheath from the catheter.
9. Wet the balloon with sterile saline.
10. Insert the IVL Connector Cable into a sterile sleeve or
probe cover.
11. Remove the cap from the proximal end and attach the
IVL Catheter’s connector (see Fig 1) to the IVL Connector
Cable.
12. Attach the other side of same IVL Connector Cable to the
IVL Generator.
Caution: Do not press the therapy button unless
the balloon is lled with 50% saline/ 50% contrast
medium because this may damage the balloon.
Delivering the IVL Catheter to the Treatment Site
1. Advance the 0.014” guidewire across the treatment site.
2. Load the IVL Catheter over the exchange length
(300cm) 0.014” guidewire and through the sheath and
advance balloon to the treatment site.
3. Position the balloon at the treatment site using the
marker bands to aid in positioning.
Treating the Site with Lithotripsy
1. Once the IVL Catheter is in place, record position using
uoroscopy.
2. If position is incorrect, adjust the IVL balloon to the
correct position.
3. Inate IVL balloon to 4.0 atm.
4. Deliver IVL System treatment sequence per the IVL
System Sequence Chart.
5. Inate balloon per balloon compliance chart (above)
and record lesion response on uoroscopy.
6. Following lithotripsy treatment, deate balloon and
wait 30 seconds to re-establish blood ow.
7. Repeat steps 3, 4, 5, 6 to complete a single treatment
with 60 pulses.
8. Additional treatments can be performed if deemed
necessary. If multiple inations are required due to
a lesion length greater than the IVL balloon length,