Indications for use:
The SenoMark™ UltraCor™ Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
Contraindications:
Patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant.
Warnings:
1) Use caution when placing near a breast implant to avoid puncture of the implant capsule.
2) Do not use in the presence of infection.
3) 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.
4) 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:
1) This product should only be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of breast tissue marker placement.
2) Store in a cool, dry place.
3) Use caution when handling the device to prevent premature deployment of the breast tissue marker.
4) Do not use if needle is bent and/or tip is damaged.
5) Ensure that all pads are dispensed.
6) 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.
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, hemorrhage, infection, adjacent tissue injury and pain.
