EN – TF11 – Precautions/ Warnings

If not used correctly Non-vascular Guidewires can lead to perforation of tissue. The damages caused by perforation may be serious and can lead to death of the patient. Tissue perforation likely occurs due to kinking of the Non-vascular Guidewires. During the use of Non-vascular Guidewires it is very important to pay attention to the insertion technique, to avoid a kinking of the wire guide. An insertion guide has to be used.

Non-vascular Guidewires contain magnetising materials such as high-grade steel and must therefore not be used under MR conditions, as heating and movement of the Non-vascular Guidewires can occur, which may lead to severe complications.

According to clinical data, a passing through strictures of > 1cm length may lead to damage or breakage of the Non-vascular Guidewires and thus should be taken into thorough consideration during surgical planning. In rare cases, repeated leading back and forth of the Non-vascular Guidewires may lead to knot building at the distal tip of the wire. The user should have appropriate 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.