Warnings
• Results of preclinical testing suggest that implant locations which expose the device to cyclic bending such as locomotive joints or muscle beds may increase the likelihood of device fracture or migration.
• The safety and effectiveness of the use of the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices in veins, in the heart, in coronary vessels, and in the neurovasculature has not been established.
• The Caterpillar™ or Caterpillar™ Micro Arterial Embolization Devices are only intended for use in the artery diameters listed in Table 1. Use in artery diameters other than those specified could result in poor occlusion and/or device migration. ]
• The Caterpillar™ or Caterpillar™ Micro Arterial Embolization Devices should be advanced and/or manipulated under fluoroscopic guidance. If the device cannot be adequately visualized under fluoroscopy, remove and discard the device and use an alternative device.
• The Caterpillar™ or Caterpillar™ Micro Arterial Embolization Devices are supplied sterile and non-pyrogenic. The device is sterilized using ethylene oxide (EtO) and is intended for single use only. Do not resterilize and/or reuse this device.
• Visually inspect the packaging to verify that the sterile barrier is intact. Do not use if the sterile barrier is opened or damaged.
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
• Do not use this device in patients with a known hypersensitivity to the materials listed below as they may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in the device, as well as for allergy/hypersensitivity to these materials. - Cobalt - Chromium - Nickel - Titanium - Platinum - Iridium - Polyurethane - Polyethylene
• The safety and effectiveness of this device has not been evaluated in children or pregnant women.
Precautions
• Check that the device has not been damaged prior to use. Do not use if any damage is visible or if any part of the implant is outside of the loader. If loader or wire kinks or becomes damaged during preparation, do not use the device.
• The device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions. The physician should determine appropriate patient compatibility with the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices prior to use. In particular, the physician should determine that the product dimensions are appropriate for the implant area.
• Physicians should exercise clinical judgment in situations that involve use of anticoagulants or antiplatelet drugs before, during and/or after use of the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices as their use may slow the rate of occlusion.
• Exercise care in handling the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices to reduce the potential of accidental damage.
• Do not advance the implant outside of the loader prior to insertion into the delivery catheter.
• Only use sterile saline to flush the device. Do not use a power injection syringe to inject contrast solution through the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices.
• Verify that the delivery catheter that is used is compatible with the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices prior to use (Section J).
• If excessive resistance beyond what would be expected is encountered at any point during advancement of the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices through the delivery catheter, stop and remove the device and delivery catheter as one unit/together.
• Do not advance or retract the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices from the loader without attaching the loader via the tuohy borst to the delivery catheter hub.
• Do not twist or rotate the delivery wire during advancement, because the implant may detach prematurely
• The Caterpillar™ Arterial Embolization Device can only be re-positioned when the Detachment Zone is still in the delivery catheter (Figure 3). If the Detachment Zone is deployed, but re-positioning is required, retrieve and discard the device. A replacement device must then be used.
• Caterpillar™ Micro Arterial Embolization Device cannot be repositioned once the distal segment is deployed. If the distal segment is deployed, but repositioning is required, retrieve and discard the device. A replacement device must then be used.
• Following deployment, use caution to prevent deformation of the membrane or implant position, including with the use of adjunctive therapies
