CONTRADICTIONS: None known.
WARNINGS: Positioning of Embolization Coils and microcoils shoud be done with particular care. Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible. A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensures permanent fixation. The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstructing a normal and essential arterial channel.
Tornado Embolization Coils and Microcoils are not recommended for use with polyurethane catheters or catheters with sideports. If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently though it. Use of a polyurethane catheter may also result in lodging of the embolus within the catheter.
If difficulties occur when deploying the embolization coil, withdraw the wire guide, coil and angiographic catheter simultaneously as a unit.
PRECAUTIONS: The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques for placements of vascular access sheaths, angiographic catheters and wire guides should be employed.
- Perform an angiogram prior to embolization to determine correct catheter position.
- Prior to Introduction of the embolization coil, flush the angiographic catheter with saline.
- If using a 0.018 inch Tornado Embolization MicroCoil, ensure that the delivery catheter has an internal diameter (ID) of .018 to .025 inch.
