Indications for Use:

The Shepherd™ Peripheral guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
 

Contraindications:

The Shepherd™ Peripheral guidewires are not intended for use in the coronary or cerebral vasculatures or in patients judged not acceptable for percutaneous intervention.
 

Warnings:

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if barrier is damaged.
• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural 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.
• Use the Guidewire prior to the “Use by” date on the package label, preceded by the symbol ⌛.
• Refer to the instructions supplied with any interventional devices to be used in conjunction with the guidewire for their intended uses, contraindications, and potential complications.
• Do not manipulate the guidewire if resistance is met. Guidewire manipulations must always be observed under fluoroscopy.
• The Peripheral family of guidewires has distal ends of varying stiffness. Operate these guidewires carefully to minimize the risk of perforation or other damage to blood vessels.
• If the guidewire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re-introduce if the guidewire is weakened or kinked.

Do Not:

• Manipulate under excessive resistance.
• Torque a guidewire if the tip becomes entrapped within the vasculature.
• Allow the guidewire tip to remain in a prolapsed condition.

Do:

• Advance or withdraw the guidewire slowly.
• Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guidewire.
• Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
• When reintroducing the guidewire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
   

Precautions:

• This device should be used only by physicians trained in percutaneous, intravascular techniques and/or procedures.
• Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may compromise guidewire performance and result in complications.
• Prior to use, confirm compatibility of guidewire outer diameter with the diagnostic or therapeutic device.
• Inspect guidewire prior to use for any surface irregularities, bends or kinks. Damaged and/or irregular guidewires should not be used.
• To avoid guidewire damage, do not withdraw the wire through a metal needle cannula.
• The tip section of the guidewire has a proper orientation for shaping. Identify the flexing plane before shaping. Shape in the same plane as that for flexure.
   

Adverse Effects:

Potential adverse events which may result from use of the device include but are not limited to:

• Hematoma and other access site complications
• Death
• Hemorrhage (bleeding)
• Reaction to contrast media
• Irritation to vessel causing vessel spasm
• Vessel dissection or perforation
• Thrombus formation
• Emergency Surgery