Cook Medical G09497 - CATHETER, ULT8.5-38-40-P-32S-CLB-RH, EACH

Cook Medical G09497 - CATHETER, ULT8.5-38-40-P-32S-CLB-RH, EACH

Biliary Drainage Catheter

Mac-Loc Locking Loop RB Design Radiopaque Band and Hydrophilic Coating

Multipurpose Drainage Catheters are constructed from Ultrathane or polyethylene and come in a range of French sizes, lengths and sideport quantities. Locking Loop Catheters are available with one of three types of locking mechanisms:

• Mac-Loc Locking Loop
• Simp-Loc Locking Loop
• Cook-Cope Type Loop

Features and Benefits

• The easy-to-use, low-profile Mac-Loc firmly fixates the 25 mm pigtail while maintaining patient comfort. Nonlocking options are available to suit physician preference.
• Ultrathane material enhances patient comfort and allows the catheter to be used safely with ethyl alcohol.
• The hydrophilic coating, when activated, becomes very lubricious, reducing friction during catheter insertion.
• The radiopaque band identifies the proximal area of the locking loop.

Components

• Catheter introduction stiffening cannula - rigid
• Catheter introduction stiffening cannula - flexible
• Securement device

Intended Use

Multipurpose drainage catheters are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

Contraindications

• Bleeding diathesis and uncontrolled hypertension
• Anticoagulant use

Precautions

• These products are intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of percutaneous drainage catheters should be employed.
• Manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.
• When inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.
• A TFE-coated wire guide must be used with Ultrathane catheters.
• Activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline. For best results, keep catheter surface wet during placement.
• Catheters should be irrigated on a routine basis to ensure function.
• Patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.
• Traction on the locking suture, if present, should be sufficient to ensure adequate retention of the tip, but should not be overly tight. Verify catheter tip configuration by fluoroscopy.
• It is recommended to use a wire guide when removing a Locking Loop catheter.
• The Peel-Away Pigtail Straightener, if present, is not to be used as a vascular introducer sheath.
• 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

Catheter Placement

• Under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by Seldinger access or trocar access.
• Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.
• For Locking Loop catheters, lock the catheter in place using appropriate technique for the locking mechanism type, as described below.

For Mac-Loc Locking Loop Mechanism:

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

• While maintaining traction on the drawstring, push the locking cam lever down until a distinct snap is felt. The distal loop of the catheter is now locked into position. (Fig. 2)

• Trim off the excess drawstring. ;(Fig. 3)
  
  

Unlocking Catheter Loop

For Mac-Loc Locking Loop Mechanism:

• While stabilizing the Mac-Loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the Mac-Loc release notch.
• Pry upward until the locking cam lever is free. (Fig. 6)
  
  
  
  NOTE: For catheter exchange, advance the distal end of a wire guide into the locked loop configuration of the catheter before unlocking the Mac-Loc assembly. Release the Mac-Loc as described above. Advance the wire guide through the catheter end hole. Catheter exchange can now be performed.

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).