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 

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

1. Under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by Seldinger access or trocar access.

2. Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.

3. For Locking Loop catheters, lock the catheter in place using appro-priate 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.

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.

c. Trim off the excess drawstring.

For Simp-LocT® Locking Loop Mechanism:

a. Stabilize the catheter near the locking sleeve with one hand, grasp the hub area of the locking sleeve and pull back. (

b. Pull the sleeve until it snaps over the shoulder of the plastic fitting on the catheter shaft. NOTE: If the locking sleeve is not fully snapped into position, the loop will not be properly secured, and leaking will occur at the locking sleeve.