Short balloon tapers for ease of deliverability and withdrawal into the introducer.

Comprehensive size offering with diameters ranging from 20mm – 40mm.

Four radiopaque marker bands to enable accurate defect sizing.

Braided inner lumen for optimal pushability, trackability and kink-resistance.

The PTS-X™ is compatible with the D’VILL™ Introducer (65cm).

WARNINGS:

• CAUTION: Do not exceed the RBP. An inflation device with pressure gauge is recommended to monitor pressure. Pressure in excess of the RBP can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.
• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.
• Do not advance the guidewire, balloon dilatation catheter, or any other component if resistance is met, without first determining the cause and taking remedial action.
• This catheter is not recommended for pressure measurement or fluid injection.
• Do not remove the guidewire from the catheter at any time during the procedure.
• This device is intended for single use only. Do not resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of cross contamination.

PRECAUTIONS:

• One should always select a PTS-X diameter larger than the unstretched defect diameter, i.e., TEE ASD size 12mm - select 20 or 25 mm PTS-X.

• Caution should be used when inflating the balloon, over inflation can cause trauma and overstretching of the septum.

• Sizing procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.

• Guidewires are delicate instruments. Care should be exercised while handling to help prevent the possibility of breakage.

• Careful attention must be paid to the maintenance of tight catheter connections and aspiration before proceeding to avoid air introduction into the system.

• Under no circumstances should any portion of the catheter system be advanced against resistance. The cause of the resistance should be identified with fluoroscopy and action taken to remedy the problem. 

• Potential complications related to the introduction of the catheter into the body include, but are not limited to, the following: infection, air embolism, and hematoma formation.

• Potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.

• Complications associated with sizing include, but are not limited to : clot formation and embolism, nerve damage, vascular perforation requiring surgical repair, damage to the vascular intima, cerebral accident, cardiac arrhythmias, myocardial infarction, or death.