Cook Medical G17203 - CATHETER, FOLEY, 01.0CC, 6FR, W/O STYL, 12/BX

Cook Medical G17203 - CATHETER, FOLEY, 01.0CC, 6FR, W/O STYL, 12/BX

Universa 2-Way Silicone Foley Catheter

The two-way Foley catheter comes in a full range of sizes, from 6-26 Fr. Choose from either a round (closed) tip or an open tip that can be placed over a wire guide. Other options include a larger, 30 mL balloon that is typically used postoperatively or under other special circumstances in which you need a larger balloon size.

Used to provide continuous drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder but may also be accomplished by suprapubic placement or nephrostomy. All-silicone construction avoids latex sensitivity concerns. Sold in boxes of 12.

Intended Use

This device is intended for use in providing continuous bladder irrigation of fluids and/or drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder but may also be accomplished by nephrostomy or suprapubic placement. Recommended indwell time for this device is 30 days. Only open end catheters are recommended for placement over a wire guide. 6.0 French catheters are recommended for neonates and non-ambulatory pediatrics.

Warnings

• Should product label contain the PHT symbol, this warning statement applies: 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.
• This device is intended for urological use only.
• Do not use petroleum-based ointments or lubricants since they may damage silicone and burst balloons.
• Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.
• Do not overinflate. Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.

Precautions

• Visually inspect the product for any imperfections or surface deterioration prior to use.
• When inflating the balloon, use a Luer syringe. Do not use a needle.
• 6.0 - 10.0 French closed-end Foley catheters may be packaged with a stylet to aid in placement. It may be necessary to apply slight tension on the balloon after inflation to ease stylet removal.
• Should balloon rupture occur, care should be taken to ensure that all balloon fragments have been removed from the patient.
• Puncture access to the bladder should only be carried out with a full bladder.
• This product is intended for use by physicians trained and experienced in suprapubic and/or nephrostomy access techniques.
• Refer to the product label or the inflation check valve on the balloon device for appropriate balloon volume.
• In the event the retention balloon cannot be deflated, transect the shaft of the catheter, allow the balloon to deflate, and remove.

Instructions for Use

Urethral Insertion

• Ensure the catheter is well lubricated then pass the deflated catheter through the urethra and into the bladder. An open-ended catheter may be introduced over a well lubricated wire guide to facilitate placement.
• Once position is confirmed (via flow of urine or aspiration of urine, if necessary), connect a syringe containing sterile media to the Luer of the inflation lumen on the two- or three-pronged Y-fitting.
• Use the syringe to fill the balloon. It is recommended the balloons fluid volume be checked periodically and then reinflated with recommended volume.
• Connect the funnel drainage lumen of the two- or three-pronged fitting to a drainage bag.
• If using a 3-way Foley catheter, the third lumen may be used to irrigate.
• Assure good drainage from the catheter.
• Secure the catheter to the skin.
• Irrigate only as needed.
• An indwelling time of more than one day requires daily maintenance of the meatus on male patients.

Suprapubic Placement

• Perform the standard techniques for establishing suprapubic access into the bladder and leave a wire guide halfway into the bladder. Use a dilator/access sheath, as necessary, and remove it after dilation.
  NOTE: A trocar and introducer may also be used for creating and maintaining access.
• Pass the deflated silicone Foley catheter through the introducer/access sheath.
• An open-ended catheter may be introduced over the external end of the wire guide; gradually advance the catheter end well into the collecting system.
• Use the syringe to fill the balloon. It is recommended the balloons fluid volume be checked periodically and then reinflated with recommended volume. Once position is confirmed (via flow of urine or aspiration of urine, if necessary), remove the wire guide.
• Connect the funnel drainage lumen of the two-or three-pronged fitting to a drainage bag.
• If using a 3-way Foley catheter, the third lumen may be used to irrigate.
• Assure good drainage from the catheter.
• Secure the catheter.
• Irrigate only as needed.

Nephrostomy Placement

• Perform the standard techniques for establishing a nephrostomy tract utilizing fluoroscopic control, leaving a wire guide in the collection system.
• An open-ended catheter may be introduced over the external end of the wire guide; gradually advance the catheter end well into the collecting system.
• If an access sheath is already in place to maintain the nephrostomy tract, remove the wire guide and pass the deflated catheter through the lumen of the sheath, ensuring it is well into the collecting system.
• Use the syringe to fill the balloon. It is recommended the balloons fluid volume be checked periodically and then reinflated with recommended volume. Confirm the position fluoroscopically.
• Connect the funnel drainage lumen of the two- or three-pronged fitting to a drainage bag.
• If using a 3-way Foley catheter, the third lumen may be used to irrigate.
• Remove the access sheath and/or wire guide.
• Assure good drainage from the catheter.
• Secure the catheter.
• Irrigate only as needed.

Catheter Removal

• Disconnect all drainage/irrigation tubes from the catheter.
• Using syringe aspiration, deflate the balloon.
• Remove the catheter.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if the 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.