MedComp PRO-PICC CT Instrucciones De Uso página 3

DESCRIPTION:
• A family of peripherally inserted central catheters made from specially formu-
lated biocompatible medical grade materials. Catheters are packaged in a tray
with accessories necessary for a percutaneous microintroducer introduction
(Modified Seldinger or Seldinger technique).
• The PRO-PICC
clamp free infusion therapy. Positive pressure into the catheter (gravity, pump,
syringe) will open the valve. When negative pressure (aspiration) is applied, the
valve opens allowing the withdrawal of blood into a syringe.
INDICATIONS FOR USE:
• The PRO-PICC
term peripheral access to the central venous system for intravenous therapy
and power injection of contrast media, and allows for central venous pressure
monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter French size and
is printed on the catheter.
• IMPORTANT INFORMATION PERTAINING TO POWER INJECTION:
• Contrast media should be warmed to body temperature prior to power injection.
Warning: Failure to warm contrast to body temperature prior to power injection
may result in catheter failure.
• Vigorously flush the PRO-PICC
and sterile normal saline prior to and immediately following the completion of
power injection studies. This will ensure the patency of the catheter and prevent
damage to the catheter. Resistance to flushing may indicate partial or complete
catheter occlusion. Do not proceed with power injection study until occlusion
has been cleared.
Warning: Failure to ensure patency of the catheter prior to power injection studies
may result in catheter failure. DO NOT exceed the maximum flow rate printed on
the catheter.
Warning: Power injector machine pressure limiting feature may not prevent over
pressurization of an occluded catheter.
Warning: Exceeding the maximum indicated flow rate may result in catheter
failure and/or catheter tip displacement.
Warning: PRO-PICC
implies the catheter's ability to withstand the procedure, but does not imply
appropriateness of the procedure for a particular patient. A suitably trained
clinician is responsible for evaluating the health status of a patient as it pertains to
a power injection procedure.
CONTRAINDICATIONS:
• The presence of device related infection, bacteremia, or septicemia is known
or suspected.
• The patient's body size is insufficient to accommodate the size of the implanted
device.
• The patient is known or is suspected to be allergic to materials contained in
the device.
• There has been past irradiation of prospective insertion site.
• There have been previous episodes of venous thrombosis or vascular surgical
procedures at the prospective placement site.
• There are local tissue factors that may prevent proper device stabilization and/or
access.
POSSIBLE COMPLICATIONS:
• Air Embolism
• Bleeding
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Cardiac Tamponade
• Catheter Erosion through the Skin
• Catheter Embolism
• Catheter Occlusion
• Catheter related Sepsis
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Exsanguination
• Fibrin Sheath Formation
• Hematoma
with valve technology controls the flow of fluids to provide
®
CT catheter with valve technology is indicated for short or long
®
®
CT catheter indication of power injection of contrast media
®
CT catheter using a 10cc or larger syringe
• Intolerance reaction to Implanted
Device
• Laceration of Vessels or Viscus
• Myocardial Erosion
• Perforation of Vessels or Viscus
Phlebitis
• Spontaneous Catheter Tip
Malposition or Retraction
• Thromboembolism
• Venous Thrombosis
• Ventricular Thrombosis
• Vessel Erosion
• Risks normally associated with
local or general anesthesia, surgery,
and post-operative recovery
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