Adverse Events; Directions For Use - Guerbet Axessio Guia Del Usuario

WARNING
WARNING
• A guidewire is a delicate instrument and must not
• A guidewire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met.
be advanced, withdrawn, or torqued if resistance is
Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or
met. Excessive force against resistance may result
vessel perforation.
in separation of the guidewire tip, damage to the
• Guidewire manipulations must always be observed under fluoroscopy to observe resultant tip response. If the
catheter or vessel perforation.
guidewire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked
• Guidewire manipulations must always be observed
segments) prior to re-introduction. Do not re-introduce if guidewire is weakened or kinked.
under fluoroscopy to observe resultant tip response.
If the guidewire is removed and is to be re-inserted,
• Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device
it must be inspected for signs of damage (weakened
may lead to injury, illness or death of the patient.
• Cleaning, disinfection and sterilization after use may compromise essential material and design characteristics
leading to device failure.
PRECAUTIONS
• Failure to follow the instructions may compromise
PRECAUTIONS
guidewire performance and result in complications.
• Failure to follow the instructions may compromise guidewire performance and result in complications.
• Inspect guidewire prior to use for any surface
irregularities, bends or kinks. Damaged and/or
• Inspect guidewire prior to use for any surface irregularities, bends or kinks. Damaged and/or irregular
irregular guidewires should not be used.
guidewires should not be used.
• To avoid guidewire damage, do not withdraw the wire
• To avoid guidewire damage, do not withdraw the wire through a metal needle cannula.
POTENTIAL ADVERSE EVENTS/COMPLICATIONS:
• Neither the guidewire insertion tool nor torque device are intended to enter the body.
Potential adverse events which may result from use of the device include but are not limited to:
• Check labeled diameter of diagnostic or therapeutic catheter and verify compatibility with the guidewire
• Additional intervention (endovascular or surgical)
diameter prior to use.
• Advancement into the subintimal space

ADVERSE EVENTS

• Allergic reaction
Procedural related complications include but are not limited to the following:
• Antigenic effect
• Vessel damage or trauma
• Arrhythmia
• Cardiac tamponade
• Air embolism, thromboembolism
• Death
• Post embolization treatment (abdominal pain, fever, and nausea/vomiting)
• Dissection
• Hematoma at the puncture site
• Embolus
• Perforation of the vessel
• Emergency Surgery
• Vessel spasm
• Failure to cross occlusion / lesion
• Hemorrhage
• Guidewire entangled/embedded within old stent
• Vascular thrombosis
• Guidewire lodged in catheter
• Guidewire fracture/separation/peeling
• Death
• Bleeding

DIRECTIONS FOR USE

The Axessio™ Guidewire with Hydrophilic Coating is to be used by a qualified, licensed physician or
• Failed Treatment
other healthcare practitioner authorized by and under the discretion of such physician.
• Inability to position guidewire
1. Prepare the interventional catheter per manufacturer instructions or other medically acceptable protocols.
• Damage to catheter
2. Remove the guidewire and protective hoop from packaging and place on sterile field. To activate
DIRECTIONS FOR USE
Hydrophilic coating, flush protective hoop with saline or per institutional protocol. A luer lock is connected to
the protective hoop to aid in flushing.
The Charter™ Guidewire with GLYCE™ Hydrophilic Coating is to be used by a qualified, licensed physician or
other healthcare practitioner authorized by and under the discretion of such physician.
3. Gently remove the guidewire from the protective hoop and inspect the wire prior to use to verify it is
undamaged. Do not grasp distal tip of wire.
1. Prepare the interventional catheter per manufacturer instructions or other medically acceptable protocols.
4. If necessary, gently shape the distal tip of the wire according to standard practices.
2. Remove the guidewire and protective hoop from packaging and place on sterile field. To activate GLYCE
Hydrophilic coating, flush protective hoop with saline or per institutional protocol. A luer lock is connected to
5. Carefully insert and advance the guidewire into the catheter. The guidewire insertion tool may be used to
the protective hoop to aid in flushing.
facilitate introduction of the guidewire into the hub of the catheter or hemostatic valve. Once inserted, remove
the insertion tool by sliding it over the proximal end of the guidewire.
3. Gently remove the guidewire from the protective hoop and inspect the wire prior to use to verify it is
undamaged. Do not grasp distal tip of wire.
6. If desired, the guidewire can be used with the torque device provided. Slip the device over the proximal end of
the guidewire. When on the desired location of the guidewire, tighten the cap of the torque device to secure
4. If necessary, gently shape the distal tip of the wire according to standard practices.
the device in place. The torque device can be repositioned or removed by loosening and/or tightening the cap.
or kinked segments) prior to re-introduction. Do not
re-introduce if guidewire is weakened or kinked.
• Reuse of single-use devices creates a potential
risk of patient or user infections. Contamination of
the device may lead to injury, illness or death of the
patient.
• Cleaning, disinfection and sterilization after use
may compromise essential material and design
characteristics leading to device failure.
through a metal needle cannula.
• Neither the guidewire insertion tool nor torque device
are intended to enter the body.
• Check labeled diameter of diagnostic or therapeutic
catheter and verify compatibility with the guidewire
diameter prior to use.
• Hematoma and other access site complications
• Hemorrhage (bleeding)
• Infection
• Irritation to vessel causing vessel spasm
• Myocardial infarction
• No true lumen re-entry
• Perforation
• Pericardial effusion
• Reaction to contrast media
• Thrombus formation
• Vessel dissection or perforation
• Vessel occlusion
• Vessel trauma/injury leading to fistula formation
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