Shockwave S4 Manual De Istrucciones página 3

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 defined 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
fluoroscopic guidance.
2. Use only the recommended balloon inflation 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 inflate 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 Effects
Possible adverse effects 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 fistula
• Bleeding complications
• Death
• Emboli (air, tissue, thrombus or atherosclerotic emboli)
• Emergency or non-emergency arterial bypass surgery
LBL 61333-D, (2019-03)
• 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 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 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 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. Flush the guidewire port with saline.
8. Remove the protection sheath from the catheter.
9. Wet the balloon and distal shaft with sterile saline in
order to activate the hydrophilic coating.
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
EN
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 filled 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
fluoroscopy.
2. If position is incorrect, adjust the IVL balloon to the
correct position.
3. Inflate IVL balloon to 4.0 atm.
4. Deliver IVL System treatment sequence per the IVL
System Sequence Chart.
5. Inflate balloon per balloon compliance chart (above)
and record lesion response on fluoroscopy.
6. Following Lithotripsy treatment, deflate balloon and
wait 30 seconds to re-establish blood flow.
7. Repeat steps 3, 4, 5, 6 to complete a single treatment
with 40 pulses.
8. Additional treatments can be performed if deemed
necessary. If multiple inflations are required due to
a lesion length greater than the IVL balloon length,
the recommended balloon overlap is at least 1 cm
to prevent geographic miss. Caution: Care must
be taken not to exceed 160 pulses in the same
treatment segment.
9. Perform a completion arteriogram to assess post
intervention result.
10. Deflate the balloon and confirm that the balloon is fully
deflated prior to removing the IVL Catheter.
11. Remove the IVL Catheter. If there is difficulty in
removing the device through the hemostatic valve due
to the lubricity, gently grasp the catheter with sterile
gauze.
12. Inspect all components to ensure that the catheter is
intact. If a device malfunction occurs or any defects are
noted on the inspection, flush the guide wire lumen
and clean the outer surface of the catheter with saline,
store the catheter in a sealed plastic bag, and contact
Shockwave Medical, Inc. for further instructions.
Caution: IVL Catheter once pulled out of the body
should not be reinserted for additional inflation or
lithotripsy treatments. Balloon can be damaged in
the process.
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