VersaCross Connect™ Transseptal Dilator Brief Summary

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

INDICATIONS FOR USE

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

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 VersaCross Connect™ Transseptal Dilator and accompanying  guidewire are intended for single patient use only. Do not attempt to sterilize and reuse the VersaCross Connect™ Transseptal Dilator or accompanying guidewire. Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another. Failure to do so may results in patient complications.
  • Careful manipulation must be performed to avoid cardiac damage or tamponade. Dilator advancement should be performed under imaging guidance. Fluoroscopic or echocardiographic imaging is recommended. If resistance is encountered, DO NOT use excessive force to advance or withdraw the device.
  • 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

  • The VersaCross Connect™ Transseptal Dilator is compatible with introducer sheaths 12.5F or larger.
  • The VersaCross Connect™ Transseptal Dilator is for use with specified models of 12F ID WATCHMAN™ Access Sheath that are 75cm in length.
  • The VersaCross Connect™ TransseptalDilator is compatible with 0.035” transseptal devices and guidewires or smaller.
  • The VersaCross Connect™ Transseptal Dilator is NOT compatible with transseptal needles such as the “NRG™ Transseptal Needle”.

ADVERSE EVENTS

Adverse events that may occur while using the VersaCross Connect™ Transseptal Dilator and accompanying guidewire include:

  • Infection
  • Air embolus
  • Local nerve damage
  • Vessel trauma
  • Vessel spasm
  • Pseudoaneurysm
  • AV fistula formation
  • Atrial septal defect
  • Arrhythmias
  • Perforation and/or tamponade
  • Hematoma
  • Hemorrhage
  • Catheter entrapment
  • Embolic events
  • Valve damage
  • Pericardial/pleural effusion
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