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Healthcare Professionals

Soloist Series

Diagnostic Catheters

  • Soloist Series Diagnostic Catheters

Indications, Safety, and Warnings

Intended Use
The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for this catheter.

Warnings

  • This device is for single use only. Do not resterilize and/or reuse. Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
  • This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
  • Electrical recording or stimulation equipment must be "front end" isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
  • Do not use in the coronary vasculature other than in the coronary sinus.
  • Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
  • US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION.

Precautions

  • To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
  • Excessive bending or kinking of catheter may damage internal electrode wires.
  • Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.