Long-Term Hemodialysis Catheter

Indications for Use:

The GlidePath™ Retro™ long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.

Contraindication:

This device is contraindicated for patients exhibiting severe, uncontrolled thrombocytopenia or coagulopathy. 

WARNING:

Percutaneous insertion of the catheter should be made into the axillary-subclavian vein at the junction of the outer and mid-thirds of the clavicle lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and clavicle and can lead to damage or fracture and embolization of the catheter.¹ Fluoroscopic or radiographic confirmation of catheter tip placement should be helpful in demonstrating that the catheter is not being pinched by the first rib and clavicle.¹ Accessories and components used in conjunction with this catheter should incorporate Luer-lock adapters. Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments are the preferred alternative. Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure. Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the skin exit site. When cleaning the exit site, inadvertent contact with the catheter is acceptable, but repeated catheter contact should be avoided. Apply antiseptic per manufacturer’s recommendations. Allow to air dry completely before applying dressing. In all cases skin cleaning/disinfection should follow local facility protocols. Any sharp or acute angles that could compromise the opening of the catheter lumens need to be avoided. Cannulation of the left internal jugular vein was reportedly associated with a higher incidence of complications compared to catheter placement in the right internal jugular vein.² Cardiac arrhythmias may result if the guidewire and/or stylet touches the walls of the right atrium. Use cardiac rhythm monitoring to detect arrhythmias. Catheters should be implanted carefully. Close all clamps only in the center of the extension legs. Extensions may develop cuts or tears if subjected to excessive pulling or contact with rough edges. Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue and possible disconnection. Do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps. Do not re-sterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by reuse of the catheter or accessories. Failure to clamp extensions when not in use may lead to air embolism. Follow Universal Precautions when inserting and maintaining this device. If a valved introducer is not used: To prevent air embolism and/or blood loss, place thumb over the exposed orifice of the sheath introducer. In the rare event of a leak, the catheter should be clamped immediately. Necessary remedial action must be taken prior to resuming dialysis or infusion procedure. Intended for Single Use. DO NOT RE-USE. Re-use and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the patient. The risk of infection is increased with femoral vein insertion. The stylet must always be removed before the guidewire is removed in order to prevent risk of perforating vessel walls. To avoid damage to vessels and viscus, infusion pressures should not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. NOTE: A three pound (13.3 Newton) force on the plunger of a 3 mL syringe generates pressure in excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) force on the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure. To prevent air embolism and/or blood loss put patient in Trendelenburg position and always place thumb over the exposed orifice of the sheath introducer. 

Precautions:

If the catheter is intended to be placed in a jugular or subclavian vein, it is recommended to place the patient on a cardiac monitor during the procedure for detection of arrhythmia. Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened/damaged or contamination is evident. Before attempting the insertion of GlidePath™ Retro catheters, ensure that you are familiar with the complications listed below and their emergency treatment should any of them occur. Care should be taken not to advance the split sheath too far into vessel as a potential kink would create an impasse to the catheter. Care should be taken NOT to force the dilator sheath introducer assembly into the vessel during insertion as vessel damage including perforation could result. Ensure that the catheter does not move out of the vein while removing the insertion stylet. Ensure that the introducer sheath is only torn externally. Catheter may need to be further pushed into the vessel as sheath is torn. For optimal product performance, do not insert any portion of the cuff into the vein. If the microintroducer guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire. Left sided placement in particular, may provide unique challenges due to the right angles formed by the innominate vein and at the left brachiocephalic junction with the SVC.^3,4 Read the instructions for use carefully before using this device. Repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure. In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp. Sterile and non-pyrogenic only if packaging is not opened, damaged or broken. Stylet is intended for use over a guidewire to aid in placement. Inserting the stylet into the venotomy without tracking over a guidewire could result in vessel damage including perforation. The complications listed below as well as other complications are well documented in medical literature and should be carefully considered before placing the catheter. Placement and care of GlidePath™ Retro catheters should be performed by persons knowledgeable of the risks involved and qualified in the procedures.

Adverse Reactions:

The use of an indwelling central venous catheter provides an important means of venous access for patients; however, the potential exists for serious complications including the following: • Air Embolism • Arteri­al Puncture • Bleeding • Brachial Plexus Injury • Cardiac Arrhythmia • Cardiac Tamponade • Catheter or Cuff Erosion Through the Skin • Catheter Embolism • Catheter Occlusion • Damage or Breakage due to Compres­sion Between the Clavicle and First Rib¹ • Catheter-related Sepsis • Endocarditis • Exit Site Infection • Exit Site Necrosis • Extravasation • Femoral Artery Bleed • Femoral Nerve Damage • Fever • Fibrin Sheath Formation • Hematoma • Hemomediastinum • Hemothorax • Hydrothorax • Infiltration • Inflammation, Necrosis or scarring of skin over implant area • Intolerance Reaction to Implanted Device • Laceration of Vessels or Viscus • Perforation of Vessels or Viscus • Phlebitis • Pneumothorax • Retroperitoneal Bleed • Risks Nor­mally Associated with Local and General Anesthesia, Surgery, and Post- Operative Recovery • Subclavian Artery Puncture • Subclavian Vein Stenosis • Duct Injury • Thromboembolism • Venous Stenosis • Venous Thrombosis • Ventricular Thrombosis • Vessel Erosion

References:

1.        Aitken D, Minton J. The “pinch-off sign”: A warning of impending problems with permanent subclavian catheters. Am J Surg. 1984;148(5):633-636.

2.      Sulek C, Blas M, Lobato E. A randomized study of left versus right internal jugular vein cannulation in adults. J Clin Anesth. 2000;12(2):142-145.

3.      Mickley V. Central venous catheters: many questions, few answers. Nephrol Dial Transplant. 2002;17(8):1368-1373.

4.      Tan P, Gibson M. Central venous catheters: the role of radiology. Clin Radiol. 2006;61(1):13-22.

Please consult product labels and inserts for complete information on indications, contraindications, hazards, warnings, precautions and directions for use.

BD, the BD logo, and GlidePath are trademarks of Becton, Dickinson and Company or its affiliates. © 2024 BD. All Rights Reserved.

BD-113864