UltraClip™ Dual Trigger Breast Tissue Marker

Indications for use: 

The UltraClip™ Dual Trigger breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. 

Contraindications:

None known.

Warnings:

1) Use caution when inserting near a breast implant to avoid puncture of the implant capsule.

2) 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.

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) Use caution when handling the device to prevent premature deployment of the marker.

2) 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 tissue marker placement.

3) 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, marker migration, misdiagnosis, adjacent tissue injury and pain.