Indication for Use
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. This device is not intended for use except as indicated above.
Warnings
- As with any foreign object implanted into the body, potential adverse reactions are possible. It is the responsibility of the physician to evaluate the risk/benefit prior to the use of this device.
- Use caution when inserting near a breast implant to avoid puncture of the implant capsule.
- 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 pyrogenic or 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. Additionally, re-use and/or repackaging may compromise the structural integrity and/or material and design characteristics of the device, which may lead to device failure, and/or lead to patient injury.
- 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.
- After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and local, state and federal laws and regulations. Dispose of sharps in designated sharps disposal containers. This product should be disposed of appropriately, not recapped or resterilized.
- Keep dry. Keep away from sunlight.
- Examine the product to ensure it has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used. Do not use if product damage or contamination is evident.
Precautions
- 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.
Potential Complications
Complications may occur at any time during or after the procedure. Potential complications of breast tissue marker placement may include, but are not limited to: hematoma/bleeding, hemorrhage, infection, lymphedema, unspecified tissue injury, pain, marker migration, allergic reaction and inaccurate marker placement, which may affect the accuracy of future tissue diagnoses.
Note: Users should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.
