UltraCor™ Twirl™ Breast Tissue Marker

The ULTRACOR® TWIRL® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

CONTRAINDICATIONS

Patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant. The implant is made from a nickel-titanium alloy; if there is a known allergy to nickel, use of the ULTRACOR® TWIRL® Breast Tissue Marker is not advised.

WARNINGS

• As with any foreign object implanted into the body, potential adverse reactions are possible. It is the It is the responsibility of the physician to evaluate the risk/benefit prior to use of this device:
• The ULTRACOR® TWIRL® Breast Tissue Marker is not recommended for use in patients with breast implants.
• This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components- are difficult or impossible to clean once body fluids or tissues with potential pyrogenicor microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
•  Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization, of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

PRECAUTIONS

• This product should only be used by a physician who is completely familiar with the indications, contraindications, limitations and typical findings and possible side effects of breast tissue marker placement.
• Do not use if needle is bent and/or tip is damaged.
•  Use caution when handling the device to prevent premature deployment of the breast tissue marker. 
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations.

POTENTIAL COMPLICATIONS

Potential complications of breast tissue marker placement may include, but are not limited to: hematoma, hemorrhage, infection, allergic reaction, marker migration, misdiagnosis, lymphedema, adjacent tissue injury, pain, and nerve injury.

Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.