Phenom™ Catheter Indications, Safety, and Warnings

INDICATIONS FOR USE

Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

CAUTION

Do not attempt to use catheters without flushing or hydrating first with saline. Failure to do so, may compromise the coating and lubricity of the catheter.

PRECAUTIONS

• This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
• Inspect the catheter prior to use for any kinks or bends. Any catheter damage may decrease the desired performance characteristics.
• Do not use if package is open or damaged. Contents of unopened, undamaged package are sterile.
• Use prior to the “Use By” Date.
• Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.

CONTRAINDICATIONS

None known.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, the following:

• Distal emboli (air, foreign material, tissue or thrombus)
• Hematoma
• Hemorrhage
• Infection
• Ischemia
• Pain at insertion site
• Neurological deficit that could lead to stroke and death
• Vessel spasm, dissection, perforation or injury

WARNINGS

• THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Reuse and/or re-sterilization can potentially result in compromised device performance and cross contamination.
• The catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
• Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the catheter against resistance may result in damage to the catheter, or the vessel.
• The infusion pressure should not exceed the listed pressure as indicated in flowrate charts (see IFU).
• Do not use catheters that are damaged in any way. Damaged catheters may break or rupture causing vessel damage or tip detachment during the procedure.
• Shaping mandrel is not for in-vivo use.