Cook Medical G07420 - RCFW-6.0-38 CHECK-FLO TM II BLUE INT, EACH
Performer Introducer Set Standard Without Wire Guide
Introducers are designed to perform as a guiding sheath and/or introducer sheath, and can be ordered with a Tuohy-Borst valve or a Check-Flo valve. Some introducers are available with a radiopaque band/tip incorporated within the sheath material to identify the location of the sheaths distal tip. Some introducers are also available with AQ hydrophilic coating to provide a lubricious surface to ease insertion.
| Order Number | Reference Part Number | Introducer Fr | Accepts Wire Guide Diameter inch | Wire Guide Tip Configuration | Sheath Length (cm) | Dilator Length (cm) |
| G07420 | RCFW-6.0-38 | 6.0 | 0.038 | - | 13 | 20 |
Device Characteristics
| What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | No |
| Device labeled as "Not made with natural rubber latex": | No |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Intended Use
Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
Warnings
Before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.
Precautions
- This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths should be employed.
- The maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer. All instruments or catheters used with this product should move freely through the valve and sheath. Damage to the valve/introducer may result when the fit is tight.
- When inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.
- Before removing or inserting devices through the introducer, aspirate through the side-arm of the valve to clear the introducer, then flush with heparinized saline.
- When inflating a balloon at, or close to, the introducer tip, ensure the balloon is not inside the distal tip of the introducer.
- When puncturing, suturing or incising the tissue near the introducer, use caution to avoid damaging the introducer.
- Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.
- Withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.
- The potential effects of phthalates on pregnant/ nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.
Instructions for Use
Sheath Introduction
- Upon removal from package, ensure the inner diameter (ID) of the introducer is appropriate for the maximum diameter of the instrument or catheter to be introduced.
- Using the side-arm of the valve, flush the introducer by filling the introducer assembly completely with heparinized saline.
- Flush the dilator with heparinized solution.
- Insert the dilator completely into the introducer and, for introducers with Tuohy-Borst valves, tighten the Tuohy-Borst valve around the dilator.
- If using an introducer with AQ hydrophilic coating, activate hydrophilic coating by wetting the outer surface of the device with heparinized saline.
NOTE: For best results, maintain wetted condition of device during placement. - Using standard Seldinger technique, access the target vessel with the appropriate needle.
- Insert wire into vessel through the needle, then remove needle, leaving wire guide in place.
- Insert dilator/sheath combination over wire guide.
- Remove wire guide and dilator, aspirate and flush introducer side-arm.
- Insert appropriately sized device as needed.
Sheath Removal
- Insert wire guide at least 10 cm past the tip of the sheath.
- Insert the introducer dilator over the wire into the sheath.
- Withdraw the sheath and dilator as a unit.
- Remove the wire guide.
How Supplied
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
