Indications for use:
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. Contraindications: These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use.
Warnings/Adverse Reactions:
• Inspect wire for damage prior to use, do not use a wire that has been bent, kinked, or damaged. Use of a damaged wire may result in vessel damage or wire fragment release into the vessel.
• Do not reshape the hydrophilic wire by any means. Attempting to reshape the wire may cause damage to the wire.
• Do not manipulate or withdraw the wire through a metal entry needle or a metal dilator, or use this wire with devices which contain metal parts such as atherectomy catheters or laser catheters or metal torque devices. This may result in destruction and /or separation of the outer polyurethane coating requiring retrieval. A plastic entry needle is recommended when using this wire for initial placement, or a catheter, introducer sheath or vessel dilator should replace the needle as soon as the guide wire has been inserted into the vessel.
• Never advance the guide wire against resistance without first determining the reason for the resistance under fluoroscopy. If resistance occurs and the cause of resistance cannot be determined, remove the guide wire and device as a unit. Excessive force against resistance may result in damage to the wire and/or to the vessel.
• When manipulating, advancing, exchanging, or withdrawing a catheter over the wire, secure and maintain the guide wire in place under fluoroscopy to avoid unexpected guide wire advancement; otherwise damage to the vessel wall by the wire’s tip may occur.
• The hydrophilic guide wire should be used only by a physician, who is well trained in manipulation and observation of guide wires under fluoroscopy.