Indications, safety, and warnings Rebar™ microcather

INDICATIONS FOR USE

The Rebar™ Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

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 with a thorough understanding of angiography and percutaneous interventional procedures.

PRECAUTIONS

• Prior to use, carefully examine the Rebar™ Micro Catheter and its packaging to verify that it has not been damaged during shipment.
• Embolic agents must be used in accordance with manufacturer’s instructions.
• Prior to use, all accessory devices and agents should be fully prepared according to the manufacturer’s instructions.
• Always monitor infusion rates when using this micro catheter.
• The micro catheter has a lubricious hydrophilic coating on the outside of the catheter. It must be kept hydrated in order to be lubricious. This can be accomplished by attaching a Y-connector to a continuous saline drip.
• When injecting contrast for angiography, ensure that the catheter is not kinked or occluded.
• When the infusion catheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the catheter without observing the resultant tip response.
• Because the Rebar™ may be easily advanced into narrow, selective vasculature, repeatedly verify (for example by slightly withdrawing the catheter) that the Rebar™ has not been advanced so far as to interfere with its removal.

CONTRAINDICATIONS

• It is not intended for use in the coronary vasculature.
• The Rebar™ Micro Catheter is contraindicated when, in the medical judgment of the physician, such a procedure may compromise the patient’s condition.
• The Rebar™ Micro Catheter is contraindicated for neonatal and pediatric use.

POTENTIAL COMPLICATIONS

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

• Hematoma at the site of entry
• Vessel perforation
• Vessel spasm
• Hemorrhage
• Pain and tenderness
• Vascular thrombosis
• Thrombolytic episodes
• Neurological deficits including stroke and death
• Ischemia

WARNINGS

• Infusion pressure with this device should not exceed pressure as specified in the package insert. Excess pressure may result in catheter rupture, which may result in patient injury.
• If flow through the micro catheter becomes restricted, do not attempt to clear the device by high pressure infusion. Either remove the micro catheter to determine the cause of the obstruction or replace it with a new micro catheter. Excessive pressure may cause catheter rupture, which may result in patient injury.
• Never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy. Excessive force against resistance may result in damage to the device or vessel perforation.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.
• For Steam Shaping Mandrel:
      - Shaping Mandrel is not intended for use in the human body.
      - Use only a steam source to shape the catheter tip. Do not use other heat sources.
      - Prior to use, inspect the catheter tip for any damage that may have resulted from shaping. Do not use a catheter that has been damaged in any way. Damaged catheters may rupture causing vessel trauma or tip detachment during steering maneuvers.