Adverse Events - Bard Solo Flex Instrucciones De Uso

• Manipulate the guidewire slowly and carefully in the urinary system while confirming the behavior and location
of the wire's tip under fluoroscopy. Excessive manipulation of the guidewire without fluoroscopic confirmation
may result in perforation or trauma of the linings or associated tissues, channels or ducts. If any resistance is
felt or if the tip's behavior and/or location seems improper, STOP manipulating the guidewire and/or the catheter
and determine the cause by fluoroscopy. Failure to exercise proper caution may result in bending, kinking,
separation of the guidewire's tip, damage to the catheter, or damage to the urinary system. If necessary, remove
the guidewire and ancillary device or scope as a complete unit to avoid complications.
• Do not attempt to use the guidewire if it has been bent, kinked or damaged. Use of a damaged wire may result
in damage to the linings and associated tissue, channels or ducts or release of wire fragments into the urinary
system.
PRECAUTIONS
• Do not use this product without reading and understanding the complete instructions enclosed herein.
• The entire operation must be carried out in a sterile field.
• Product is sterile in an unopened and undamaged unit package. Do not use if the unit package or the guidewire
is broken, damaged or soiled. Return any defective product to Bard. The B
P Hybrid Guidewires should be used immediately after opening the package. All the guidewires should be
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disposed of safely and properly after use, following local regulations for medical waste management.
• When using a drug or a device concurrently with The B
Guidewires, or any other polymer-coated wire, the operator should have a full understanding of the properties/
characteristics of the drug or device so as to avoid damage to the wire.
• The surface of the guidewire is not lubricious unless it is wet. Before taking it out of its holder and inserting it
through a catheter, fill the holder and the catheter with physiological saline solution.
• The guidewire should be advanced through the scope using short, deliberate 2-3 cm (0.8" - 1.2") movements to
prevent inadvertent damage to the device or patient.
• When reinserting the guidewire back into the holder, take care not to damage the wire's coating with the edge of
the holder.
• Do not use a metal torque device with the guidewire. Use of a metal torque device may result in damage to the
wire. Also do not slip a tightened up torque device over the wire, as this may result in damage to the wire.
• Due to variations of certain catheter tip inner diameters, abrasion of the hydrophilic coating may occur during
manipulation. If any resistance is felt during introduction of the catheter, it is advisable to stop using such
catheters.
• After removal from the patient's urinary system, and prior to reinserting it into the same patient during the same
catheterization, hydrophilic tipped guidewires should be rinsed in a bowl full of physiological saline solution. Use
of alcohol, antiseptic solutions or other solvents must be avoided because they may adversely affect the surface
of the guidewire.

ADVERSE EVENTS

Complications which can result from the use of guidewires in urological applications include:
• Perforation of the urinary tract
• Acute Bleeding
• Hemorrhage
• Tissue Trauma
• Edema
• Foreign Object in Body
• Infection
• Hemoglobinuria
• Peritonitis
• Ureter Avulsion
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