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Prescriptive information
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended use / Indications for use
AccuStick II Introducer System
The AccuStick II Introducer System with radiopaque marker is intended to facilitate introduction and placement of a guidewire utilizing non-vascular percutaneous access.
Stainless Steel and Nitinol Guidewires
These non-vascular guidewires are intended to facilitate introducer needle, dilator, or sheath exchange in percutaneous access procedures.
Contraindications
There are no known contraindications.
Warnings
- The AccuStick II is not intended for use in the vascular system.
- Carefully read all instructions prior to use of this product. Observe all warnings and precautions, failure to do so may result in complications.
- Avoid positioning or moving the guidewire without observing the tip response, as this may result in misplacement of the guidewire or patient injuries.
- Avoid advancing, withdrawing and/or rotating the guidewire against resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or tissue trauma and other patient injuries.
- Exercise care in handling of the guidewire during a procedure to reduce the possibility of breakage, bending, kinking, or coil separation. Do not use a guidewire that has been damaged.
- Inspect the device prior to use for any surface irregularities and bends or kinks.
- Do not use if the device is damaged, irregular or any component detachment is detected before or during the procedure; breaks or deformations may result in tissue trauma or need for additional intervention or surgery.
Precautions
- Prior to use, inspect both the sterile seal and the device for any damage.
- Do not use devices that are damaged.
- When advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.
- Use of incompatible devices may result in damage to the guidewire.
- Inspect the device for damage, bends, or kinks prior to use.
Potential adverse events
Potential adverse events which may be associated with the use of this system and/or procedure include, but are not limited to:
- Allergic reaction (device, other)
- Bleeding/hemorrhage
- Edema
- Extravasation
- Fever
- Fistula
- Hematoma
- Infection/sepsis
- Inflammation
- Necrosis
- Need for additional intervention
- Pain/discomfort
- Perforation of an organ
- Pneumothorax
- Tissue damage including laceration and scarring
- Unretrieved device fragment(s)
- Vessel trauma (dissection, laceration, perforation, other injury)
90960661 AC