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Indications, safety and warnings for SEISMIQ

Prescriptive information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

SEISMIQ Intravascular Lithotripsy Over-The-Wire Peripheral Catheter

Intended use / Indications for use

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.

Contraindications 

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. 

Warnings

  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. 

Precautions

  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.

Potential adverse events

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 

PI-2227203-AB

SEISMIQ Intravascular Lithotripsy Console 

Intended use / Indications for use

The SEISMIQ IVL Console is intended for use only in conjunction with SEISMIQ IVL Catheters. Refer to the individual SEISMIQ IVL Catheter directions for use for specific indications.

The SEISMIQ IVL Console is intended to be used by experienced medical personnel in a catheterization lab. This device should only be used following an arteriogram (or CT or MRI) of the vascular system.

Contraindications 

There are no specific contraindications for use of the SEISMIQ IVL Console. However, users should read and understand the specific indications, contraindications, warnings, and precautions included with the applicable SEISMIQ IVL Catheter directions for use.

Warnings

General warnings

Do not operate the SEISMIQ IVL Console until you have read this user manual and the user manual provided with the SEISMIQ IVL Catheter. An understanding of the features, functions, indicators, and connectors of the Console is a prerequisite for the proper use of this equipment and before clinical use. The SEISMIQ IVL Console is only compatible with the SEISMIQ IVL Catheters and related accessories

Shock hazard

To avoid the risk of electrical shock, this equipment must only be connected to a grounded electrical outlet (electrical supply mains with protective earth). Use with a hospital grade receptacle. Grounding reliability can only be achieved when connected to an equivalent receptacle marked "hospital use" or "hospital grade".

Do not attempt to service the System. It contains no operator serviceable components and dangerous high voltages may be present. No user modification or servicing of this equipment is allowed. If any part of this product appears damaged, remove from use, and contact your Bolt Medical representative for repair or replacement.

Fire hazard

Do not immerse any portion of the Console in water or other fluids. Avoid spilling any fluids on the Console. Spilled liquids may cause the Console to perform inaccurately or malfunction. Do not clean with solvents or flammable agents as this may cause damage to the Console and possibly cause harm to the user. Do not autoclave or sterilize the Console as this may cause the Console to malfunction.

Possible fire

Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during therapy. 

Electrical interference hazards

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could affect the performance of this device. If use of equipment in close proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. Do not operate the Console near cauterizers, diathermy equipment, or other portable and mobile RF communications equipment. Contact your Bolt Medical representative if assistance is required.

Possible electrical interference

Using cables, catheters, or accessories not specified for use with this product may result in increased emissions and/or decreased immunity from electromagnetic or radio frequency interference (RFI) which could affect the performance of this product or of equipment in close proximity. Use only parts and accessories specified in these operating instructions. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be no closer than 30 cm (12 inches) to any part of the Console including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential ENVIRONMENT (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Saftey risk and possible equipment damage / possible injury or skin burns 

The Console and its accessories (including Catheters) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage and affect the performance of the equipment. Consult the MRI manufacturer for more information.

Use environment

Allow the Console and its accessories (including Catheters) to adjust to room temperature and humidity conditions for at least twenty-four hours before use. See Appendix B for specified operating conditions. Operating the equipment outside of these environmental conditions may cause equipment malfunction or damage.

Improper device performance hazards

Using other manufacturer’s catheter or power adapters may cause the device to perform improperly and may invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

Laser safety

This product is a Class 1 Laser Product.

Stability hazard

Do not position on an angled surface or push the Console from any point other than the handle. Tipping or overbalance may ensue.

Proper ventilation

Allow for a minimum of 6 inches or 15 centimeters of unobstructed clearance around the Console for ventilation to prevent overheating.

Warning shock hazard

To avoid the risk of electrical shock, this equipment must only be connected to a grounded electrical outlet (electrical supply mains with protective earth). Use with a hospital grade receptacle. Grounding reliability can only be achieved when connected to an equivalent receptacle marked “hospital use” or “hospital grade”.

Do not contact HDMI connectors while touching the patient at the same time.

Warning use environment

Operating the SEISMIQ IVL Console outside of the environmental conditions may cause equipment malfunction or damage.

Warning

Do not immerse any portion of the Console in water or other fluids. Avoid spilling any fluids on the Console. Spilled liquids may cause the Console to perform inaccurately or malfunction.

Do not clean with solvents or flammable agents as this may cause damage to the Console and possibly cause harm to the user.

Do not autoclave or sterilize the Console as this may cause the Console to malfunction.

Precautions

General cautions

The SEISMIQ IVL Console is intended for use by a physician, or on the order of a physician. Prior to using the Console, the user should be familiar with the controls and functions of the Console described in this manual. Do not press more than one button at a time on the Console. The Console may not respond to either user input. If the shipping container has been damaged in transit or if any part of this product appears damaged, cracked, chipped, or missing, remove from use and contact your Bolt Medical representative for repair or replacement.

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 device 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.

Catheter movement hazard

Use caution to prevent unintentional movement of the Catheter during treatment. Failure to comply with this recommendation could result in an injury to the patient.

Equipment damage

The Console delivers laser energy pulses to the Catheter through the catheter cable. The Console is designed not to deliver pulses unless a catheter connector is mated with the Console. It is important not to allow the contacts or internal surfaces of unmated connectors to be contaminated with fluids. Do not allow any connector to become contaminated by or immersed in fluids. Failure to observe these precautions may damage the Console.

Catheter damage

The Catheters require inflation pressure using the correct mixture of 50% contrast and 50% saline to operate reliably. Deliver therapy pulses only when the balloon contains fluid and is located within the body during treatment. Only inflate the balloon to the specified pressure ranges indicated in the SEISMIQ IVL Catheter directions for use. Failure to observe these precautions may damage the catheter balloon and could possibly result in patient injury.

Disposal

The user should follow the local and national regulations for disposal of electronic components when dispensing of this Console. Contact your Bolt Medical representative and / or email complaints@boltmed.com for product returns.

Caution

The SEISMIQ IVL Console delivers laser energy pulses to the SEISMIQ IVL Catheter. The Console is designed not to deliver pulses unless a connector is mated with the Console. It is important not to allow the contacts or internal surfaces of unmated connectors to be contaminated with fluids. Do not allow any connector to become contaminated by or immersed in fluid. Failure to observe these precautions may damage the cables or Catheters.

Caution

Do not attempt to service the Console. It contains no operator serviceable components. Dangerous high voltages and Class 4 laser radiation may be present. No user modification or servicing of this equipment is allowed.

If any part of this product appears damaged, remove from use and contact your Bolt Medical representative or email complaints@boltmed.com. 

Potential adverse events

None.

PI-2227102-AB