Indications for use

The SenoMark™ UltraCor™ MRI Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.

Contraindications

This device is not intended for use except as indicated.

Warnings

1) 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.

2) 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.

3) Avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip. 4) Patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant.

5) This device is not recommended for use in patients with breast implants.

6) Do not use in the presence of infection.

7) 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.

Precautions

1) This device should only be used by physicians trained in percutaneous biopsy procedures.

2) Do not use if Temperature Indicator is black.

3) Do not use if the product sterile barrier system or its packaging is compromised.

4) Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident and/or needle is bent.

5) Ensure all pads are dispensed.

6) Published studies with comparably sized 316L stainless steel biopsy markers have shown no maker movement and insignificant marker heating when tested in an MRI system with a 1.5T field strength.

Complications

Potential complications may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and migration.