Cook Medical G09498 - ULT10.2-38-40-P-32S-CLB-RH BILIARY DRNG, EACH

Cook Medical G09498 - ULT10.2-38-40-P-32S-CLB-RH BILIARY DRNG, 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

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

• The easy-to-use, low-profile Mac-Loc mechanism firmly fixates the loop while maintaining patient comfort.
• 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 marks the location of the most proximal sideport.

Included Components

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

Biliary Drainage Animation

Contraindications

• Bleeding diathesis and uncontrolled hypertension
• Anticoagulant use

Warnings

If a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.

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:

• a. 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)
• b. 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)
• c. Trim off the excess drawstring. (Fig. 3)

Unlocking Catheter Loop

For Mac-Loc Locking Loop Mechanism:

• a. 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.
• b. 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.

For Simp-Loc Locking Loop Mechanism:

• a. Partially insert the appropriate stiffening cannula into catheter for support. (Fig. 7)
• b. Grasp the locking sleeve just beyond the hub and advance forward over the shoulder of the plastic fitting and proximal catheter shaft (Fig. 8) until it stops. This will release the loop. NOTE: Advance the stiffening cannula into the catheter so its distal tip is only a few centimeters beyond the locking sleeve portion of the catheter.

NOTE: For catheter replacement, total removal of the Simp-Loc mechanism is recommended. With Simp-Loc in locked position, cut completely through the locking sleeve near the hub, advance
the remaining locking sleeve forward over the plastic fitting to expose suture ends, and pull one suture end completely out of the catheter. If resistance is encountered, a slight tugging motion may be required to free the suture from the catheter. Standard wire guide exchange procedure for catheter replacement can now be performed.