EN – TF11 – Contraindication
- Contraindications for guide wires > 0.014“ (0.35 mm) can be Chronical Total Occlusion (CTOs).
- Guide wires containing magnetising materials such as high-grade steel and may therefore not be used under MR conditions, as heating and movement of the guide wire can occur, which may lead to catastrophic complications.
- Certain cases of entrapped or breakdown Non-vascular Guidewires are reported as well as possible techniques to retrieve the entrapped or broken parts. The user should have knowledge in such techniques in order to prevent serious consequences related to such events.
- If coated Non-vascular Guidewires are used special attention has to be paid to the combination product (e.g. catheter) to avoid damages to the integrity of the coating.
- Malposition of the catheterizing Non-vascular Guidewires may lead to serious complications.
- This device shall not be used in contact with central circulatory system and/or the central nervous system.
