VIA™ Indications, Safety, and Warnings

Warnings and Precaution

Warnings:

• CAUTION: This device should be used only by physicians trained in percutaneous, intravascular and neurovascular techniques and procedures at medical facilities
  with the appropriate fluoroscopic equipment.

• The VIA Microcatheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged.

• Do not use if the packaging is damaged. Use before expiration date noted on the product packaging.

• The VIA Microcatheter is intended for single use only.

• Do not resterilize and/or reuse the device. Reuse and/or resterilization can increase risk of infection, cause a pyrogenic response or other life-threatening complications. Reuse and/or resterilization can degrade product performance, leading to device malfunction. Dispose of all devices in accordance with applicable
  hospital, administrative and/or local government policy.

• Never advance or withdraw a device against resistance until the cause of the resistance is determined by fluoroscopy. Excessive force against resistance may result in damage to the device or vessel perforation.

• Always monitor infusion rates when using the microcatheter.

• When injecting contrast for angiography, ensure the catheter is not kinked or occluded.

• Do not exceed 300 psi maximum recommended infusion pressure. Excess pressure may result in catheter damage or patient injury.

• Steam shaping may result in improper device delivery and deployment, depending on the degree of shaping and catheter deflection during device delivery.

• Using the VIA Microcatheter with guide catheters smaller than what is recommended (see compatability table above) may result in damaging the hydrophilic coating.

• The VIA Microcatheter has not been evaluated for use in the pediatric population

Precautions:

• Prior to use, examine the VIA Microcatheter to verify that it has not been damaged during shipment.

• The VIA Microcatheter has a lubricious hydrophilic coating on the outside of the catheter. It must be kept hydrated in order to be lubricious. This can be accomplished by attaching a Y-connector to a continuous saline drip.

• High quality, digital subtraction fluoroscopic road mapping, with orthogonal views, is mandatory to achieve correct placement of the microcatheter and embolization device.

• If repositioning is required, take special care to retract or to advance the device under fluoroscopy.

• The operator should be aware that microcatheters, in distal blood vessels, may increase the risk of thromboemboli.

• Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors, when possible. The risk of X-ray radiation exposure complications may increase as procedure time and number of procedures increase.

• If removed from the patient, the hydrophilic coating on the VIA Microcatheter should be hydrated with heparinized saline. Do not allow the coating to dry as this may impact the coating safety and performance.

• Avoid pre-soaking devices for long durations when the device is not in use as this may impact the coating safety and performance.

• Avoid wiping the device with dry gauze as this may damage the device coating.

• Avoid excessive wiping of the coated device.