Indications, safety, and warnings Phenom™ catheters

INDICATIONS FOR USE

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

CAUTION

• Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
• This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

POTENTIAL COMPLICATIONS

Potential complications of the devices and the endovascular procedure include or are synonymous with, but may not be limited to the following:

• Pain at insertion site
• Hematoma
• Hemorrhage
• Infection
• Sensitization or an allergic reaction
• Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
• Distal emboli (air, foreign material or thrombus)
• Vessel spasm, dissection, perforation or injury
• Ischemia
• Stroke that could lead to Neurological deficit and death

* Consult instructions for use for other therapy devices and medications for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.

CONTRAINDICATIONS

There are no known contraindications.

WARNING

1. 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.
2. The Phenom™ Catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
3. Never advance or withdraw an intraluminal 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.
4. The infusion pressure should not exceed the listed pressure as indicated in Flow Rate Table (listed in IFU).
5. Nickel (CAS 7440-02-0) is present in the Phenom™ Catheter and may cause sensitization or an allergic reaction.
6. The catheter has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device because it may damage the device.
7. Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.
8. For additional Materials of Concerns information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship.
9. 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.
10. Shaping mandrel is not for in-vivo use.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.