INDICATIONS, SAFETY, AND WARNINGS SiteSeer™ Diagnostic Catheter

INDICATIONS FOR USE

Cardiovascular angiographic catheters are intravascular diagnostic catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.

CONTRAINDICATIONS

None known.

WARNINGS

• For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.
• When clinical features indicate that ostial disease can reasonably be expected, the use of 5F and smaller diagnostic catheters should be approached with caution. Due to the possibility of 5F and smaller catheters passing through an ostial lesion, detection of ostial disease may be more difficult.¹
• While in the vascular system, the catheter should always be filled with either flushing solution or contrast medium to prevent or reduce clotting and air embolism. Use of systemic heparinization should be considered.
• Cardiovascular angiographic catheters are to be used with guide wires to ensure easy introduction of the catheter.
• At no time should the catheter be advanced or withdrawn when resistance is met without determining cause by fluoroscopic examination.

PRECAUTIONS

• To prevent kinking and to provide additional support of the 4F Pigtail Catheter into the Left Ventricle, use a .035" guide wire.
• Use catheters prior to expiration date stated on the package label.
• Cardiovascular angiographic catheters should only be used by or under the supervision of physicians trained in intravascular angiographic procedures.
• It is recommended that PTFE coated guide wires be used with cardiovascular angiographic catheters to enhance thromboresistance and lubricity.
• Inspect the catheter carefully prior to use to verify the size, shape, and condition of the catheter as suitable for intended procedures.
• Store catheters in a cool, dry area.
• These catheters are supplied sterile and nonpyrogenic. If catheter package is opened or damaged, do not use catheter.
• After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

ADVERSE EVENTS

• Arterial, venous or heart wall damage or perforation
• Thrombus formation
• Plaque dislodgement
• Embolization
• Vascular occlusion
• Cardiac arrhythmia
• Myocardial infarction
• Stroke
• Death
• Hematoma at the puncture site
• Infection
• Allergic reaction to contrast media

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for the full product information.