iCross™ Coronary Imaging Catheter

Prescriptive Information

Prior to use, please see the complete Directions for Use for more information on indications, contraindications, warnings, precautions, adverse events and operator's instructions.

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Intended Use/Indications

This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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Contraindications

Use of this imaging catheter is contraindicated where introduction of any other catheter would constitute a threat to patient safety. Contraindications include: Bacteremia or sepsis, Major coagulation system abnormalities, Patients disqualified for CABG surgery, Patients disqualified for PTCA, Severe hemodynamic instability or shock, Patients diagnosed with coronary artery spasm, Total occlusion.

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Complications

The following complications may occur as a consequence of intravascular ultrasound imaging: Arterial dissection, injury or perforation; Total occlusion; Death; Abrupt closure; Acute myocardial infarction; Ventricular fibrillation; Unstable angina; Air embolism.

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Warnings

Do not advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis. If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously.

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Precautions

Contents supplied sterile using a gamma radiation (Cobalt 60) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Store in a cool, dark place. During the procedure, inspect the catheter carefully for any damage which may have occurred during use. The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Do not attempt to connect the catheter to electronic equipment other than the designated systems. Never attempt to attach or detach the catheter while the motor is running. To do so may damage the connector. Avoid any sharp bends, pinching or crushing of the catheter. Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. An insertion angle greater than 45 degrees is considered excessive. Care should be taken when a guide wire is exposed in a stented vessel. Catheters that do not encapsulate the guide wire may engage the stent between the junction of the catheter and guide wire. Care should be taken when readvancing a guide wire after stent deployment. A guide wire may exit between stent struts when recrossing a stent that is not fully opposed to the vessel wall. Subsequent advancement of the catheter could cause enlargement between the catheter and the stent. Care should be taken to slowly remove the catheter from a stented vessel. Turn the MDU “off” before withdrawing the imaging catheter.

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CAUTION: Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.

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Trademark

iCross is a registered trademark of Boston Scientific Corporation