Cook Medical G26655 - INTRODUCER, SUPRAPUBIC, 20F, SANT-20-20-PLV, EACH

Cook Medical G26655 - INTRODUCER, SUPRAPUBIC, 20F, SANT-20-20-PLV, EACH

One-Step Suprapubic Introducer

The One-Step Suprapubic Introducer provides convenient bladder access when you need to place a drainage catheter. With One-Step, you can puncture, dilate and gain access, all with one simple device.

• Trocar Stylet
• Dilator
• Peel-Away Sheath

Features and Benefits

• The removable trocar stylet allows you to confirm, via urine flow, that the device is in the bladder. You can use the Luer lock on the dilator for aspiration if necessary.
• The dilator is removable so you can place a drainage catheter.
• The Peel-Away sheath splits into two parts so you can remove it while the catheter remains in place.
• Set consists of a trocar stylet, dilator and Peel-Away sheath. Supplied sterile in peel-open packages.

Intended Use

Used for introducing a drainage catheter suprapubically into the bladder.

Precautions

• Introducers are intended for use by physicians trained and experienced in techniques for suprapubic access.
• Ensure patient has a full and palpable bladder for correct bladder position.

Potential Adverse Events

Complications that might occur during this procedure could include incorrect location at insertion, resulting in trauma to the surrounding tissue.

Instructions for Use

• Using aseptic technique, remove the introducer from its outer packaging and place in the sterile field. Prepare the puncture site in the usual manner. Ensure the patient has a full and palpable bladder to confirm urine return.
• Inspect the introducer to ensure no damage has occurred during shipment. Defective devices should be returned to Cook.
  NOTE: Remove the needle tip protector prior to insertion.
• Ensure components are assembled into one piece.
• Use a scalpel to make a small incision at the puncture site. Advance the assembled components with one single pass suprapubically into the bladder.
• Remove the trocar stylet to confirm the device is within the bladder by return of urine flow. If spontaneous urine flow is not established, a syringe may be attached to the dilator for aspiration.
  NOTE: Only proceed if a flow of urine is confirmed.
• Remove the dilator from the PeelAway Sheath to allow placement of an appropriately sized drainage catheter through the sheath.
  CAUTION: The outer diameter of drainage catheters vary from manufacturer to manufacturer. Care should be taken to verify the drainage catheter will pass through the Peel-Away Sheath prior to suprapubic insertion.
• Insert the drainage catheter as usual through the sheath. Using each side of the Peel-Away Sheath, gently pull back and split the sheath into two parts while leaving the catheter in situ.

How Supplied

Supplied sterilized by ethylene oxide gas in peelopen 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.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).