Pristine™ Long-Term Hemodialysis Catheter

Indications:

The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and infusion. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion. Catheters may be inserted percutaneously.  

Contraindications: 

Thrombosed vessels · Confirmed infection, bacteremia or septicemia · Inadequate anatomy for placement of the device · Known or suspected sensitivity to the device materials · Prior or unresolved venous thrombosis at the proposed placement site.

Warnings and Precautions: 

The catheter should be inserted and removed only by a qualified, licensed physician or other healthcare professional authorized by and under the direction of such physician. · The medical techniques and procedures described in these instructions do not represent ALL medically acceptable protocols, nor are they intended as a substitute for the physician’s experience and judgment in treating any specific patient. · The content of this pack is supplied EO (Ethylene Oxide) STERILE, non-pyrogenic. · Use aseptic technique during catheter insertion, use, maintenance and removal. · Do not use the device if the “Use-By” date indicated on the package label has passed. Do not use the catheter if package has been previously opened or damaged. Inspect the device package and content to verify that no damage has occurred as a result of shipping, handling and/or storage. If damage to the sterile barrier or the device is noted, do not use the device. Retain the package with the contents and notify your BD representative. · Single patient use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness or death. Reuse, reprocessing or re-sterilization may create a risk of contamination to the device and/or may cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Keep the catheter extension tubing clamped at all times when not in use and fill the catheter with sterile saline prior to implantation to avoid air embolism. With each tubing change, purge air from the tubing and aspirate any air from the catheter. · If the catheter is intended to be placed in a internal jugular or subclavian vein, it is recommended to place the patient on a cardiac monitor during the procedure for detection of arrhythmia. · To avoid vessel perforation and damage, do not forcibly insert the guidewire, dilators, or valved pull-apart sheath/introducer. · Do not insert the valved pull-apart sheath/introducer further than necessary: depending upon patient size and access site, it may not be necessary to insert the entire length of the introducer into the vessel. · The valved pull-apart sheath/introducer is not a hemostasis valve. It is designed to reduce blood loss and the risk of air intake. · The valved pull-apart sheath/introducer is not intended to create a complete two-way seal nor is it intended for arterial use. · When using a “J” end guidewire straighten the end allowing introduction into the introducer needle. Do not insert or withdraw the guidewire forcibly from any component: the wire could break or unravel. · After placement of the catheter check for catheter tip location by imaging. · Do not nick the catheter when suturing. · Do not excessively tighten the suture when tying at the venotomy site. · Prolonged exposure to ultraviolet light can damage the catheter. · Acetone and Polyethylene Glycol (PEG)-containing ointments should not be used with polyurethane catheters. · Alcohol disinfectants (or alcohol containing antiseptics, such as chlorhexidine) may be used to clean the catheter; however, care should be taken to avoid prolonged or excessive contact with the solution. · The following antiseptics, chlorhexidine gluconate 4% (Hibiclens™), sodium hypochlorite (ExSept Plus™), povidone iodine (Povidone ointment, Betadine™ solution) and hydrogen peroxide can be used on the catheter and at the exit site; however, care should be taken to avoid prolonged or excessive contact with the solution. Solution should be allowed to completely dry before applying a dressing. Intermixing of these solutions has not been tested and is not recommended. · The following antibiotics, mupirocin 2% ointment, Polyspoirn™ ointment and gentamicin can be used on the catheter and at the exit site. · Avoid excessive tightening of catheter’s connections when connecting bloodlines, caps or syringes. Overtightening might crack the connections. · Do not clamp the dual lumen portion of the catheter; clamp only the extensions. Use only smooth-jawed forceps for clamping when not using the clamp supplied with the catheter. · Clamping the catheter repeatedly in the same spot could weaken the tubing: change the position of the clamp regularly to prolong the life of the tubing. Avoid clamping near the adapter and hub. · Exercise caution when using sharp instruments near the catheter. Catheter tubing can tear when subjected to nicks, excessive force, or rough edges. · Inspect the catheter frequently for nicks, scrapes, cuts, etc. which could impair its performance. · When injecting heparin solution, inject quickly and clamp extension while under positive pressure. Heparin solution volume to lock each lumen must be equal to the priming volume of each lumen. Priming volumes are marked on each lumen. · Remove the catheter as soon as it is no longer necessary. · Catheter removal should be performed by adequately trained healthcare professional or delegate. During catheter removal, do not cut the catheter prior to removal from the vein to prevent the occurrence of an air embolism. If there is resistance as the catheter is being withdrawn from the vein, avoid aggressive pulling to reduce the resistance. · Free the cuff and surfaces from the tissue prior to removal. When removing the catheter, DO NOT use a sharp, jerking motion or undue force; this may tear the catheter. · After use, dispose of the product and its packaging in accordance with administrative and/or local, state and federal laws and regulations. · Never use after expiry date. · To avoid damage to the vessels and viscus, infusion pressure must not exceed 25psi (172 kPa); the use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. Subclavian access should only be used when no other upper-extremity or chest-wall options are available. · To prevent air embolism, keep the catheter clamped at all times when not attached to a syringe, IV tubing, or bloodlines. · 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. · As reported in literature, left sided catheter placement may provide unique challenges due to the right angles formed by the innominate vein and at the left brachiocephalic junction with the SVC. · If arterial blood is aspirated, remove the needle and apply immediate pressure to the site for at least 15 minutes. Ensure that the bleeding has stopped and that no hematoma has developed before attempting to cannulate the vein again. · Do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire. The introducer needle must be removed first. · 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. · Place a thumb over the orifice of the sheath to minimize blood loss and risk of air aspiration. · The risk of infection is increased with femoral vein insertion. Avoid exit site at groin area. · DO NOT pull tunneler out of the primary incision at an angle. Keep tunneler straight to prevent damage to the catheter tip. The catheter can be bent slightly. · Care should be taken NOT to force the dilator sheath introducer assembly into the vessel during insertion as vessel damage including perforation could result. As reported in literature, left sided catheter placement may provide unique challenges due to the right angles formed by the innominate vein and at the left brachiocephalic junction with the SVC. · Cardiac arrhythmias may result if the guidewire is allowed to touch the walls of the right atrium.  · 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. · To prevent air embolism and/or blood loss, place thumb over the exposed orifice of the sheath introducer. · 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. · Do not allow the catheter to move out of the vein with the sheath. Ensure that the vein is not bleeding around the catheter. · 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. · Do not suture through any part of the catheter. · Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin ointment) are the preferred alternative. · Before flushing, pull the plunger back to verify blood flow and to ensure that there are no blood clots. Do not flush clots through the catheter (see Thrombi Formation). · Never forcibly flush an obstructed lumen. · Thrombolytic agents may cause systemic fibrinolysis if infused into circulation. Refer to the manufacturer’s instructions, indications for use and contraindications before using Thrombolytic agents. Stereptokinase is not recommended, it has been reported to be anaphylactogenic. · Keep the catheter clamped at all times except for when connected to the bloodlines or syringe during treatment. · 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. Hand cleaner solutions are not intended to be used for disinfecting BD hemodialysis catheter Luer-lock connectors.

Potential Complications: 

Air embolism · Arterial puncture · Brachial plexus injury · Cardiac arrhythmia · Cardiac tamponade · Catheter erosion or  extrusion through the skin · Catheter occlusion or breakage · Catheter thrombosis · Catheter tip migration or malposition · Deep vein thrombosis - lower extremity · Endocarditis · Exit site infection · Exsanguination · Extravasation · Femoral artery bleed · Femoral artery damage · Femoral artery dissection · Femoral nerve damage · Femoral vein occlusion · Fibrin sheath formation · Hematoma · Hemorrhage · Hemothorax · Hydrothorax · Inferior vena cava injury · Intolerance reaction to implanted device · Lower extremity ischemia · Mediastinal widening · Pneumothorax · Pulmonary emboli · Pulmonary embolism · Retroperitoneal bleed · Right arterial puncture · Sepsis · Subclavian artery puncture · subclavian vein stenosis · Subcutaneous tunnel infection · Superior vena cava puncture · Thoracic duct injury · Thoracic duct laceration · Thrombosis of vein · Trauma to major vessel or right atrium · Tunnel infection · Venous stenosis

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions.

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