Cook Medical G17156 - ULTRATHANE, NEPH, 10.2 FR, 25CM, 085510, EACH

Cook Medical G17156 - ULTRATHANE, NEPH, 10.2 FR, 25CM, 085510, EACH

Ultrathane Nephrostomy Set with Mac-Loc

Used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage. The Mac-Loc locking-loop mechanism provides a reliable, easy-to-use suture fixation system for drainage catheters. The locking cam lever provides the ability to vary the degree of loop fixation according to loop location and patient anatomy. The distal 5 cm of the catheter has hydrophilic coating.

Included Components

Intended Use

Used to access the uterine cavity for saline infusion sonohysterography or for injection of contrast medium into the uterine cavity and fallopian tubes for evaluation of tubal patency.

• A syringe is included.
• The small diameter allows passage through the cervix.

Contraindications

• None known

Warnings

• None known

Precautions

• Periodic evaluation is advised; the catheter should not remain indwelling more than four months.
• 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

NOTE: A TFE-coated wire guide must be used with this catheter.

• By preliminary plain film, I.V.P., retrograde pyelogram, ultrasound, or CAT scan, localize the kidney to be drained. A prone or slightly oblique position is preferred. Under fluoroscopic control, identify and anesthetize the skin site overlying the collecting system.
• Using local anesthesia, introduce the 21 gage needle below the twelfth rib. Advance the needle in short steps toward the lower pole until the needle is seen moving with respiration. While the patient holds his or her breath, advance the needle no further than 3 cm. If urine is not aspirated, repeat the process using a slightly different angle until a calyx is successfully punctured.
• Thread the .018 inch (0.46 mm) diameter wire guide through the needle; maneuver the wire guide into the pelvis or proximal ureter. Remove the 21 gage needle. Advance the 6.3 French introducing catheter with 20 gage cannula over the wire guide into the calyx. Holding the cannula stationary, further advance the catheter to follow the wire guide into the pelvis and ureter.
• Remove the wire guide and cannula. Decompress and irrigate the collecting system.
• Align the curved tip of the Safe-T-J wire guide with the curve of the introducing catheter. Introduce the flexible tip of the wire guide into the catheter and advance it until the wire guide exits the sideport of the introducing catheter. If the advancing wire guide encounters resistance, withdraw it slightly and then advance it with a slight rotary motion. When the tip of the Safe-T-J wire guide is within the renal pelvis, carefully withdraw the catheter. NOTE: Care must be exercised to avoid withdrawal of the wire guide.
• To facilitate passage of the nephrostomy catheter, dilate the musculofascial tract by progressing from the smallest to the largest dilator provided.
  NOTE: Prior to use, immerse AQ catheter in sterile water or isotonic saline to allow the hydrophilic surface to absorb water and become lubricious. This will ease placement under standard conditions.
• Pass the Ultrathane nephrostomy catheter over the external end of the wire guide; gradually advance the catheter into the collecting system. If it becomes difficult to advance the catheter, insert the catheter introduction stiffening cannula over the wire guide and into the catheter. Some lubricant may be helpful.
• Confirm the position fluoroscopically. While holding the shaft of the catheter securely in position with one hand, withdraw the wire guide (and stiffening cannula, if used) with the other.
• Lock the distal loop in place. NOTE: See Mac-Loc locking loop mechanism instructions at the end of these instructions.
• Attach the retention disc to the catheter shaft 1 to 2 cm from the skin surface. To prevent the catheter from being accidentally displaced forward, fix the retention disc in position by gluing or suturing.
• The connecting tube provides a convenient, secure method of attachment to standard urine drainage pouches. The optional stopcock may be used for intermittent patency check.

Mac-Loc Locking Loop Mechanism

To Lock

• Stabilize the Mac-Loc catheter hub assembly with one hand and pull back on the monofilament to form the distal catheter loop configuration (Fig. 1).
• While maintaining traction on the monofilament, push the locking cam lever down until a distinct snap is felt. The catheters distal loop is now locked into position (Fig. 2).
• Trim off the excess monofilament (Fig. 3).

To Unlock

• While stabilizing the Mac-Loc catheter hub assembly with one hand, position the end of a small, sterile straight or curved forceps into the Mac-Loc release notch.
• Pry upward until the locking cam lever is free (Fig. 4).
• It is now possible to remove the catheter.

Catheter Exchange

• Before unlocking the Mac-Loc catheter hub assembly, advance the distal end of a wire guide into the locked loop configuration of the catheter.
• Release the Mac-Loc as directed above.
• Advance the wire guide through the catheter end hole. Catheter exchange may now be performed in a standard fashion.

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 the package, inspect the product to ensure no damage has occurred.