Merit Medical Centros FLO IFU - Manual (Page 3)

LONG-TERM HEMODIALYSIS CATHETER
INSTRUCTIONS FOR USE
INDICATIONS FOR USE:
• The Centros® and CentrosFLO™ chronic hemodialysis catheter
are indicated for use in attaining long-term vascular access for
hemodialysis and apheresis.
• Catheter may be inserted percutaneously and is primarily placed in
the internal jugular vein of an adult patient.
• This catheter is indicated for > 30 days (long term) placement.
• Catheter should be removed in accordance with Center for Disease
Control (CDC) and Kidney Disease Outcomes Quality Initiative
(K-DOQI) guidelines.
CONTRAINDICATIONS:
• This catheter is intended for long-term vascular access only and
should NOT be used for any purpose other than indicated in these
instructions.
• This catheter is not intended for pediatric use.
• The valved peelable introducer sheath is NOT designed for use in
the arterial system or as a hemostatic device.
Read instructions for use carefully before using device.
DESCRIPTION:
• The Centros and CentrosFLO chronic hemodialysis catheter is a
dual lumen radiopaque catheter with a polyester cuff. The catheter is
15 French, featuring an innovative, dual radiused distal configuration.
Some configurations have distal arterial and venous sideholes. This
distinctively shaped design is intended to leverage the outside of
the arc of both the arterial and venous lumens with the intention of
eliminating the vein walls as an obstruction.
• By convention, the outflow lumen carrying blood from the body is
called “arterial” and is marked red and the lumen returning blood is
called “venous” and is marked blue.
POTENTIAL COMPLICATIONS: Before attempting the insertion of the
catheter, the physician should be familiar with the following compli-
cations and their emergency treatment should they occur:
• Air Embolus
• Allergic Reactions
• Bacteremia
• Bleeding at the site
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Cardiac Tamponade
• Catheter damage due to compression between
clavicle and first rib
• Catheter Embolism
• Catheter Occlusion
• Catheter or cuff erosion through the skin
• Central Venous Thrombosis
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Exsanguination
• Extravasation
• Fibrin sheath formation
• Hemothorax
• Hematoma
• Hemorrhage
• Inflammation
• Necrosis or scarring of skin over the implant area
• Laceration of the Vessel
• Lumen Thrombosis
• Mediastinal Injury
• Perforation of the Vessel
• Pleural Injury
• Pneumothorax
• Pulmonary Emboli
• Retroperitoneal Bleed
• Right Atrial Puncture
• Risks normally associated with local and general
anesthesia, surgery, and post-operative recovery
• Septicemia
• Spontaneous Catheter Tip Malposition or
Retraction
• Subclavian Artery Puncture
• Subcutaneous Hematoma
• Superior Vena Cava Puncture
• Thoracic Duct Laceration
• Thrombocytopenia
• Thromboembolism
• Tunnel Infection
• Ventricular Thrombosis
• Vessel Erosion
• Vascular Thrombosis
WARNINGS: • In the rare event that a hub or connector separates
from any component during insertion or use, take all necessary steps
and precautions to prevent blood loss or air embolism and remove
catheter.
• Do not advance the guidewire or catheter if unusual resistance is
encountered.
• Do not insert or withdraw the guidewire forcibly from any
component. The wire may break or unravel. If the guidewire
becomes damaged, the introducer needle (or sheath introducer)
and guidewire must be removed together.
• Use of excessive force on the catheter may cause the suture wing
to detach from the bifurcate.
• In the event that a clamp breaks, replace the catheter at the
earliest opportunity.
• This catheter is for single patient use only.
• Do not resterilize the catheter or accessories by any method.
• Do not reuse, reprocess or resterilize.
• Reuse, reprocessing or resterilization may compromise the struc-
tural integrity of the device and/or lead to device failure which, in
turn, may result in patient injury, illness or death.
• Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or 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.
• Contents sterile and non-pyrogenic in unopened, undamaged
package.
• Do not use catheter or accessories if package is damaged.
• Do not use catheter or accessories if any sign of product damage is
visible.
STERILIZED BY ETHYLENE OXIDE
RX Only: CAUTION: Federal Law (USA) restricts the device to sale by
or on the order of a physician.
CATHETER PRECAUTIONS:
The Centros and CentrosFLO hemodialysis catheter materials have
been tested for compatibility with the following cleaning solutions:
•
ChloraPrep®
• Alcavis® 50
• Aqueous-based Povidone Iodine
• Shur-Clens®
• Epi-Clenz®
• Hydrogen peroxide
• Silver sulfadiazine cream 1%
®