FG11150-0615-2S

Indications, Safety, and WarningsCaution

Federal (United States) 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.

Indications for usePhenom™ catheters are intended for introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.Potential complicationsPotential 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.ContraindicationsThere are no known contraindications.WarningsThis 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 Phenom™ 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 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.The infusion pressure should not exceed the listed pressure as indicated in the flow rate table (listed in the indications for use).Nickel (CAS 7440-02-0) is present in the Phenom™ catheter and may cause sensitization or an allergic reaction.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.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.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.Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at www.medtronic.com/manualsUS-NNP-2400091 (v1.0)

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