Indications, safety and warnings for SEISMIQ Intravascular Lithotripsy Over-The-Wire Peripheral Catheter

The SEISMIQ Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.

The SEISMIQ 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.

For DFU 012482
The SESMIQ IVL System is contraindicated for the following:

1. Unable to pass 0.014 in (0.36mm) guidewire across the lesion.

1. Physicians must read and understand these instructions prior to using the device. Failure to abide by the warnings in this labeling might result in damage to the device and/or its hydrophilic coating.
2. This device is intended for single (one time) use only. Do not re-sterilize and/or reuse. 
3. Do not use a device past the expiration date on the label. Use of expired product may result in patient injury. 
4. Use only an appropriately sized balloon for the vessel to be treated. Oversizing increases the risk of perforation. To reduce the potential for vessel damage, the inflated diameter of the device should be approximately a 1.1 to 1 ratio of the diameter of the vessel just proximal and distal to the stenosis. 
5. Inflate the balloon according to the balloon compliance chart. Balloon pressure should not exceed the rated burst pressure (RBP). 
6. When the device is exposed to the vascular system, it should be manipulated while under adequate fluoroscopic observations. 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. 
7. Use the SEISMIQ IVL Console in accordance with recommended settings as stated in the Operator’s Manual. 
8. This device should only be used by physicians who are familiar with interventional vascular procedures. 
9. Do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury. 
10. 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. 
11. During preparation and position of the device, it is important that all air and fluid are excluded from the inflation lumen of the device until the balloon is in position at the lesion site. 
12. Use only recommended balloon inflation medium (50/50 Contrast Media and saline). Never use air or any gaseous medium to inflate the balloon. Failure to do so can result in inadequate device performance or patient injury. 
13. Do not activate IVL Therapy with the balloon located outside the patient’s body. Activation of the IVL Therapy with the balloon located outside the patient’s body may result in exposure of the patient or medical personnel to hazardous radiation with associated risk of eye injury. 
14. Do not use a catheter that is kinked or otherwise visibly damaged. Use of a catheter that is kinked or otherwise damaged may result in exposure of the patient or medical personnel to hazardous radiation.
15. For preparation, operation, warnings and precautions, and maintenance of the SEISMIQ IVL Console and its accessories refer to the SEISMIQ IVL Console Operator’s Manual. 
16. Do not use the device if the protective sheath or shipping mandrel are difficult to remove or cannot be removed.

For DFU 012482

7. This device should only be used by physicians who are experienced in interventional vascular procedures.

1. Appropriate anticoagulant therapy should be administered by the physician.
2. Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. 
3. Care should be taken not to kink the catheter. If kinking occurs, remove catheter and use a new device. 
4. If an inability to inflate or maintain pressure occurs, remove the catheter and use a new device. 
5. If the catheter appears not to deliver lithotripsy pulsatile mechanical energy, remove the catheter and use a new device. 
6. Do not exceed the maximum number of pulses in the same treatment segment noted above in the IVL Sequence Chart. See Table 3. 
7. 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 per hospital protocol. 

Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. The SEISMIQ IVL System is a Class I laser product when used as intended in accordance with the instructions provided here. Activation of the IVL Therapy with the balloon located outside the patient’s body may result in exposure of the patient or medical personnel to hazardous radiation with associated risk of eye injury. Caution: Refer to the SEISMIQ IVL Console Operator’s Manual for preparation, operation, warnings and precautions, and maintenance of the console. 

Caution: In the event the connector is removed from the console immediately reattach the cap onto the connector. Failure to do so may result in damage to the connector upon reattachment into the SEISMIQ IVL Console. 

Caution: Do not press the therapy button unless the balloon is filled with 50% saline/ 50% contrast medium because this may damage the balloon. 

Caution: Do not disconnect the indeflator from the catheter while under vacuum. Disconnection could result in air ingress into the catheter resulting in inadequate lithotripsy.

Caution: Care must be taken not to exceed the maximum number of pulses in the same treatment segment as noted above in the SEISMIQ IVL Sequence Chart.

Caution: Once removed from the body, the SEISMIQ IVL Catheter should not be reinserted for additional inflation or lithotripsy treatments. The balloon can be damaged in the process.

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  

• 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 (including Shock/pulmonary edema) 

• Inflammation  

• Ischemia

• Placement of a stent 

• Pseudoaneurysm 

• Renal failure  

• Restenosis of the treated segment 

• Total occlusion of the peripheral artery 

• Toxicity 

• 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) 

• Device malfunction or failure 

• Excess heat of SEISMIQ IVL Catheter at target site due to malfunction of SEISMIQ IVL Console