Cook Medical G48162 - SET, ULTRATHANE, ULT10.2-10.2-22-NUCL-B-RH, EACH

Cook Medical G48162 - SET, ULTRATHANE, ULT10.2-10.2-22-NUCL-B-RH, EACH

Cope Nephroureterostomy Stent

The Cope Nephroureterostomy Stent is constructed of Ultrathane and comes in two variations. Products with an "-A" suffix in their order numbers have sideports in the loops only, and are used for bypassing lacerated ureters. Products with a "-B" suffix in their order numbers have sideports in the loops and in the entire distal segment, and are used for all other stenting purposes. Both "A" and B stents are available with one of two locking mechanisms: the Mac-Loc Locking Loop or the Cook-Cope Type Locking Loop.

Used for internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.

• The easy-to-use, low-profile Mac-Loc locking mechanism firmly fixates the proximal pigtail within the kidney while maintaining patient comfort.
• The hydrophilic coating, when activated, becomes very lubricious, reducing friction during stent insertion.
• The proximal radiopaque band offers enhanced visibility for accurate positioning in the kidneys.
• Ultrathane material enhances patient comfort and allows the device to be used safely with ethyl alcohol.

Hydrophilic Coating
Mac-Loc Locking Loop with Radiopaque Band

Intended Use

The Cope Nephroureterostomy Stent is intended for internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.

Warnings

• Stents with Cook-Cope Type Locking Loop mechanisms contain NATURAL
• RUBBER LATEX. Possible allergic reactions should be considered.

Precautions

• This product is intended for use by physicians trained and experienced in placement of nephroureterostomy stents. Standard techniques should be employed.
• Manipulation of product requires fluoroscopic control.
• A TFE-coated wire guide must be used with this product.
• Activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline. For best results, maintain wetted condition of device during placement.

Instructions for Use

Stent Placement

• Using standard percutaneous access technique, establish wire guide position well into the bladder.
• Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.
• After establishing proper proximal and distal position, push the stent off the stiffening cannula over the wire, making sure the distal pigtail forms within the bladder.
• Verify final position of the stent via fluoroscopy, then carefully withdraw the wire guide.
  NOTE: Contrast medium in the collecting system can be diluted by injection of saline solution.
• Form the proximal pigtail loop in the kidney using appropriate technique for the locking mechanism type as described below, then fix the catheter at the skin surface and apply dressings.

For Mac-Loc Locking Loop Mechanism:

• Stabilize the Mac-Loc hub assembly with one hand and pull back on the suture to form the distal stent loop configuration. (Fig. 1)

Unlocking Catheter Loop
For Mac-Loc Locking Loop Mechanism:

• Pry upward until the locking cam lever is free. (Fig. 4)
• Withdraw stent.
  NOTE: For stent exchange, advance the distal end of a wire guide into the locked loop configuration of the stent before unlocking the Mac-Loc assembly. Release the Mac-Loc as described above. Advance the wire guide through the distal end of the stent until you have an adequate length of wire guide in the bladder. Stent exchange can now be performed.