Home » Physicians » Products and Practice Support » Products » Important Risk Information
 

Important Risk Information

Please refer to full Instructions for Use on how to use these medical devices.

  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
VenaCure 1470nm Laser

INDICATION FOR USE
The AngioDynamics, VenaCure 1470 laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

CONTRAINDICATIONS
Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; an inability to ambulate; severe arterial disease; deep vein thrombosis or those with a history of DVT’s; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

WARNINGS AND PRECAUTIONS
Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using VenaCure EVLT procedure kits. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications.

CAUTION
Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. VenaCure EVLT procedure kits are intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates on the VenaCure EVLT procedure kits are still valid. Laser protective eyewear must be worn by everyone in the treatment room, including the patient. Treatment of a vein located close to the skin surface may result in a skin burn.

POTENTIAL COMPLICATIONS
Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

DELTA Series Diode Laser

WARNINGS
This product is NOT intended for use with CO2 laser systems. To clean an unenergized fiber during a procedure, gently wipe along the axis of the fiber tip with sterile water on a sterile gauze pad. Allow the fiber to cool prior to wiping with sterile water. Do not use abrasive materials or sharp objects to remove residue. No coaxial cooling is required on the bare fibers. Overheating may change the shape of the tip, power density, and therapeutic tissue effects. Do not use a damaged tip. Visually inspect the tip prior to use. Proper eye protection must be worn by all personnel and patients in the treatment area. To avoid tissue adhesions to the tip, power should be applied only briefly as the tip is lifted away from the tissue. The fiber tips can be damaged by rough handling. Do NOT subject this device to impact stress. Always inspect the tip after such incidents to ensure that no damage has occurred. The surgeon must be cautious in injecting an organ with CO2 gas or air as insufflators because in doing so, an air embolism or gas embolism may occur. When working with any laser near sensitive structures (arteries, bowel, etc.) the potential for perforation always exists. It is important that the user be aware of this possibility.

SAFETY PRECAUTIONS
The Precision 980™ Diode laser is a Class IV laser per FDA 21 CFR 1040.10 and 21 CFR 1040.11. A Class IV laser is hazardous to the eye from the direct beam and diffuse reflections. It also represents a significant skin and fire hazard. Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures in the area where the laser is being used.

NeverTouch® Procedure Kit

INDICATION FOR USE
The AngioDynamics, Inc. VenaCure EVLT™ NeverTouch® - FRS Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. The VenaCure EVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

Exclusions
Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral artery disease as determined by an Ankle- Brachial Index <0.9.

SAFETY PRECAUTION
All persons in the treatment room must be wearing protective glasses with the proper rating for the wavelength being used.

POTENTIAL COMPLICATIONS
The potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.

WARNINGS

Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not re-use the fibers or re-sterilize the fibers.

PRECAUTIONS
Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a diameter of 20 cm. Clinical safety and effectiveness data is not available for other fiber tip designs and diameters. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage.


VenaCure EVLT™ Hydrophilic-Coated Trè-Sheath™ Introducer

INDICATION FOR USE
The VenaCure® Hydrophilic-Coated Trè-Sheath® Introducer is intended for use in endovascular occlusion of the Great Saphenous Vein (GSV) in patients with superficial vein reflux and for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV). The VenaCure® Hydrophilic-Coated Trè-Sheath® Introducer is indicated for use with 810 nm and 980 nm Diode Lasers.

Exclusions:
Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral artery disease as determined by an Ankle-Brachial Index < 0.9

CAUTIONS
For single use only. Do not reuse or resterilize. This device is sterilized by ethylene oxide. Physician should be familiar with insertion techniques of introducers using a guide wire (Seldinger / Modified Seldinger). Percutaneous introducer sheaths should not remain indwelling without internal support of the sheath wall. Care should be exercised during insertion, manipulation and withdrawal of the catheter or dilator through the hemostasis valve. The integrity of the hemostasis valve may be compromised with the use of excessive force or rapid withdrawal. If resistance is encountered: DO NOT FORCE. Remove the catheter or dilator and introducer as a unit. If repositioning of the sheath is necessary, ensure that internal support is provided by a vessel dilator and guidewire prior to insertion to avoid twisting the sheath. Upon withdrawal of a device, the side port should be aspirated in order to remove any clotted material that may have accumulated. This should be accomplished before the insertion of another medical device.

WARNINGS
Care should be exercised during insertion, use or removal of the device to prevent aspiration of air into the vasculature. Rapid withdrawal of the catheter or dilator through the hemostasis valve may cause misalignment of the valve gasket assembly, causing bleedback through the valve. In this scenario, the slow reinsertion of a vessel dilator tip or catheter should realign the valve stopping bleedback. Inspect the packaging and product for damage prior to use. Do not use if the package is damaged as sterility may be compromised. Tighten all connections prior to use without overtightening. Over tightening can cause damage to the components. Periodically check all connections for tightness. Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not place emitting section of the laser fiber in contact with the vessel wall during operation, since it may cause perforations to the vessel wall.

PRECAUTIONS
Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage. The sheath size must be compatible with the laser fiber.

POTENTIAL COMPLICATIONS
The potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescense, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.


Spotlight OPS

INDICATIONS
The Laser and Procedure Kit are intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein, and with veins in the lower limbs with superficial reflux. The D15 Plus, D30 Plus, DELTA-15 and DELTA-30 lasers and Kits are indicated for treatment of incompetent refluxing veins in the superficial venous system.

CONTRAINDICATIONS
Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

COMPLICATIONS
Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burns, and thrombophlebitis.

WARNINGS
Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel.

PRECAUTION
Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a radius of 60 mm. The positions of the sitemarks on the VenaCure EVLT fiber have been matched to the introducer sheath provide in the VenaCure EVLT procedure kit. Alternative sheaths must not be substituted. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage. Do not coil the sheath tighter than a radius of 60 mm. The entry needle provided with this kit is matched to the size of the guidewire and should not be substituted. Do not tighten the compression clamp on sheath until fiber is in position.

NOTE: Patients on anticoagulant therapy are still eligible for treatment. Most physicians will only treat patients with an I.N.R. (Internal Normalized Ratio) at the lower therapeutic limits. It is sometimes helpful to nick the skin with a scalpel at the puncture site either to aid insertion of the needle, or after guidewire insertion.

The VenaCure EVLT™ system can be performed under local anesthesia in the physician’s office or as an outpatient treatment. The VenaCure EVLT™ system must only be performed by a qualified physician who has received specialized training in the techniques described.

Sotradecol Injection

Sotradecol is contraindicated in patients with previous hypersensitivity to the drug; inflammation or incompetence of superficial or deep veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; diabetes; toxic hyperthyroidism; tuberculosis; asthma; neoplasm; sepsis; blood dyscrasias; and acute respiratory or skin diseases.

Due to the risk of deep vein thrombosis, patients should be evaluated for valvular competency and deep venous patency before treatment and slow injections of a small volume (< 2 mL) should be injected. Patients should be monitored post-treatment for deep vein thrombosis and pulmonary embolism. Extreme caution must be exercised in the presence of underlying arterial disease.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site.

Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution, it is recommended that 0.5 mL of Sotradecol be injected, followed by observation for several hours before administration of a second or larger dose. Emergency resuscitation equipment should be immediately available, and the physician prepared to treat an anaphylactic reaction.

At least 6 deaths have been reported. Four of the deaths were cases of anaphylaxis; one in a patient with a history of asthma, a contraindication to Sotradecol use. Another death was in a patient who was taking an antiovulatory agent. One death (pulmonary embolism) occurred in a patient not taking an antiovulatory agent, treated with sodium tetradecyl acetate. Other adverse reactions reported include pulmonary embolism; local injection site reactions (pain, urticaria, ulceration); permanent discoloration of sclerosed vein segment; sloughing and necrosis of tissue following extravasation of the drug; allergic reactions (hives, asthma, hayfever); headache; nausea; and vomiting.

Please see full Prescribing Information for more information here.