Indications, safety, and warnings for SureFlex™ Steerable Guiding Sheath

INDICATIONS FOR USE

The SureFlex™ Steerable Guiding Sheath kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

CONTRAINDICATIONS

There are no known contraindications for this device.

WARNINGS

• Laboratory staff and patients can undergo significant x-ray exposure during interventional procedures due to the continuous usage of fluoroscopic imaging.  This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects.  Therefore, adequate measures must be taken to minimize this exposure. The use of echocardiography is recommended.
• The SureFlex Steerable Guiding Sheath kit is intended for single patient use only.  Do not attempt to sterilize and reuse the SureFlex Steerable Guiding Sheath kit.  Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another. 
• Care should be taken to ensure that all air is removed from the sheath before infusing through the side port.
• Care should be taken when inserting or removing accessory devices from the sheath. For example, if removing the dilator, any devices through the dilator shall be removed as well.
• Do not attempt direct percutaneous insertion of the sheath without the dilator as this may cause vessel injury.
• Damage to guidewire may result if withdrawn through a metal needle cannula.
• Maintain continuous hemodynamic monitoring throughout procedure.
• Provide continuous heparinized saline infusion while the introducer remains in vessel.
• To minimize vacuum effects during withdrawal, remove components/aspirate slowly. Refrain from aspiration if a wire is directly through the valve.
• Avoid contact with liquids other than blood, isopropyl alcohol, contrast solution or saline.
• Prior to steerable sheath’s delivery and removal, ensure distal section is as straight as possible.
• Do not kink, stretch, or severely bend steerable sheath.
• Do not use surgical instruments to handle sheath.
  • The sheath device shaft in its entirety is coated with a hydrophobic lubricious coating for smoother device manipulation. The following warning must be considered:
  • Excessive wiping and/or wiping with a dry gauze may damage the coating.
• The guidewire is coated with a lubricious coating. The following warnings must be considered:
  • Use with incompatible introducers or dilators may affect device performance and integrity, including coating integrity.
  • Excessive manual bending and/or shaping of the device may affect the coating integrity.
• DO NOT attempt to insert or retract the guidewire through a metal cannula or a percutaneous needle, which may damage the guidewire and may cause patient injury.

PRECAUTIONS

• Careful manipulation must be performed to avoid cardiac damage, or tamponade. Sheath, dilator and guidewire advancement should be done under fluoroscopic guidance.  Echocardiographic guidance is also recommended. If resistance is encountered, DO NOT use excessive force to advance or withdraw the device.
• The SureFlex Steerable Guiding Sheath kit is supplied STERILE using an ethylene oxide process.
• The sterile packaging and all components should be visually inspected prior to use.  Do not use if the device, packaging or sterile barrier have been compromised or damaged.
• Do not attempt to use the SureFlex Steerable Guiding Sheath kit before thoroughly reading the accompanying Instructions for Use.
• Only physicians or personnel trained in aseptic techniques should perform aseptic presentation. 
• Only physicians thoroughly trained in the techniques of the approach to be used should perform interventional procedures. 
• Do not use device after its “Use By” date.
• Avoid deflecting distal end of sheath during delivery and removal, otherwise damage to vessels may occur.
• Do not reshape distal tip or curve of the guidewire. Excessive bending or kinking of the distal curve may damage the integrity of the wire or coating and lead to patient injury.
• Only use compatible tip straighteners with the guidewire.
• Do not attempt to insert the proximal end of the guidewire as the distal end.
• Confirm ancillary devices are compatible with the dilator and guidewire diameters before use.
• Individual patient anatomy and physician technique may require procedural variations.
• Do not attempt to use the guidewire with electrocautery tools.
• Avoid guidewire contact with liquids other than blood, isopropyl alcohol, contrast solution or saline.

ADVERSE EVENTS

Adverse events that may occur while using the SureFlex™ Steerable Guiding Sheath include:

• Infection
• Air embolus
• Local nerve damage
• Vasovagal reaction
• Dissection
• Vessel spasm
• AV fistula formation
• Atrial septal defect
• Pseudoaneurysm
• Aortic puncture
• Arrhythmias
• Perforation and/or tamponade
• Hematoma
• Hemorrhage
• Catheter entrapment
• Embolic events
• Stroke
• Valve damage
• Myocardial infarction
• Pericardial/pleural effusion
• Pacemaker/defibrillator lead displacement
• Pulmonary edema
• Coronary artery spasm and/or damage
• Vessel trauma

97186428 (Rev. A)