WEB™ Embolization System Indications, Safety, and Warnings

Warnings and Precautions

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.
CAUTION: The WEB embolization device should be used by physicians who have received appropriate training for this device.
CAUTION: Using this device in a catheter that is not recommended or required may result in extreme friction and damage to the device.
The WEB Aneurysm Embolization System 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 WEB Aneurysm Embolization System is intended for single use only. The detachment control device is intended to be used for one patient. 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.
The WEB embolization device must be delivered only through a compatible microcatheter with a PTFE inner surface coating. Damage to the embolization and delivery device may occur and necessitate removal of both the device and microcatheter from the patient.