Indications, safety, and warnings for TorFlex™ Transseptal Guiding Sheath

INTENDED USE/INDICATIONS FOR USE

The TorFlex Transseptal Guiding Sheath kit is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

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 TorFlex Transseptal Guiding Sheath kit is intended for single patient use only. Do not attempt to sterilize and reuse the TorFlex Transseptal Guiding Sheath kit. Reuse can cause patient injury and/or the transmission of infectious disease(s) from one patient to another.
• The TorFlex Transseptal Guiding Sheath kit is supplied sterile using an ethylene oxide process. Do not use if the package is damaged. If damage is found, call your Boston Scientific representative. 
• The entire shaft of the sheath device is coated with a lubricious coating. The following warnings must be considered: 
  • Use of the sheath with introducer sheaths smaller than 11 F may result in a tight fit that affects device performance, including coating integrity. 
  • Excessive wiping and/or wiping of the sheath with a dry gauze may damage the coating. 
• The Mechanical 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. 
• 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 the dilator and catheters from the sheath.
• Do not attempt direct percutaneous insertion of the sheath without the dilator as this may cause vessel injury.
• Careful manipulation must be performed to avoid cardiac damage or tamponade. Sheath advancement should be done under fluoroscopic guidance. Echocardiographic guidance is also recommended.

PRECAUTIONS

• Do not attempt to use the TorFlex Transseptal Guiding Sheath kit before thoroughly reading the accompanying Instructions for Use.
• Careful manipulation must be performed to avoid cardiac damage, or tamponade. Sheath, dilator and guidewire advancement should be done under fluoroscopic guidance. If resistance is encountered, do not use excessive force to advance or withdraw the device.
• The sterile packaging and sheath should be visually inspected prior to use. Do not use the device if it has been compromised or damaged.
• 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.
• Note product “Use By” date. 
• The TorFlex Transseptal Guiding Sheath is compatible with introducer sheaths 11 F or larger.
• Do not reshape the 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 TorFlex Transseptal Guiding Sheath kit include, but are not limited to, the following: 

• Allergic Reaction 
• Arrhythmias 
• Cardiac Arrest 
• Cardiac Trauma 
• Catheter Entrapment 
• Cerebral Vascular Accident 
• Death 
• Embolism 
• Fistula 
• Heart Failure 
• Hematoma 
• Hemorrhage 
• Inflammation/Infection 
• Myocardial Infarction 
• Nerve Injury 
• Pacemaker/Defibrillator Lead Displacement
• Pain 
• Pericardial Effusion/Tamponade 
• Radiation Exposure 
• Respiratory Insufficiency/Failure 
• Thrombosis 
• Transient Ischemic Attack 
• Vasovagal Reaction 
• Vessel Trauma

There may be other potential adverse events that are unforeseen at this time.

97186431 (Rev. B)