RF3000™ Radiofrequency Ablation System
Radiofrequency Ablation
Indications, Safety, and Warnings
Prescriptive Information
RF3000 Radio Frequency Generator
INTENDED USE/INDICATIONS FOR USE
The RF 3000 Generator is intended only for use in conjunction with the LeVeen and Soloist Needle Electrode Families for the thermal coagulation of soft tissue.
CONTRAINDICATIONS
None known.
WARNINGS
Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on factors under the control of the operator. It is important that the instructions supplied, both with this equipment and the accessories, be read, understood, and followed in order to ensure safety and effectiveness. No modification of this equipment is allowed The use of RF energy can produce unintended neuromuscular stimulation. The use of electrosurgical devices can cause electromagnetic interference (EMI) in other devices, particularly cardiac pacemakers. Precautions should be taken to ensure that the patient’s well-being is maintained in the event of such interference. The use and proper placement of dispersive electrodes (return pads) is a key element in the safe and effective use of monopolar electrosurgery, particularly in the prevention of burns. Follow the manufacturer’s Instructions for Use.
POTENTIAL ADVERSE EVENTS
Refer to the individual LeVeen Electrode or Soloist Electrode Directions for Use manual for specific observed and/or potential adverse events.
LeVeen Needle Electrode Family
INTENDED USE/INDICATIONS FOR USE
The LeVeen Needle Electrode Family is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved.
PRECAUTION
Before using, inspect the package for any breach to the sterile barrier and inspect product for any damage. If package is broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific.
WARNINGS
- The colored insulated cannula must be used at all times when accessing tissue. Use of the electrode without the colored insulated cannula may result in serious burns to the patient and/or user.
- Damage to the insulation of the introducer may result in serious burns to the patient and/or user.
- Precaution: The LeVeen Needle Electrode Family must be used in conjunction with the Boston Scientific RF 3000 ™ Generator.
- For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.
ADVERSE EVENTS
Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:
- Abscess
- ARDS (Acute Respiratory Distress Syndrome)
- Arrhythmia
- Ascites
- Biloma
- Burn
- Death
- Delayed hemorrhage into ablated tissue
- Diarrhea
- Electric Shock
- Fistula, including biliary fistula
- Hematoma
- Hemorrhage
- Infection
- Liver Failure
- Liver Insufficiency
- Pain
- Perforation
- Peritonitis
- Persistent Fever > 39° C
- Pleural Effusion
- Renal Failure
- Tumor Recurrence
- Tumor Seeding
Soloist Single Needle Electrode
INTENDED USE/INDICATIONS FOR USE
The Soloist Single Needle Electrode is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
CONTRAINDICATIONS
None known.
WARNINGS
- Damage to the insulation of the introducer or needle may result in serious burns to the patient and/or user.
- Precaution: The Soloist™ Single Needle Electrode must be used in conjunction with the Boston Scientific RF 3000™ Generator.
- For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.
ADVERSE EVENTS
Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:
- Abscess
- ARDS (Acute Respiratory Distress Syndrome)
- Arrhythmia
- Ascites
- Biloma
- Burn
- Death
- Delayed hemorrhage into ablated tissue
- Diarrhea
- Electric Shock
- Fistula, including biliary fistula
- Hematoma
- Hemorrhage
- Infection
- Liver Failure
- Liver Insufficiency
- Pain
- Perforation
- Peritonitis
- Persistent Fever > 39°C
- Pleural Effusion
- Renal Failure
- Tumor Recurrence
- Tumor Seeding