Indications for use:
The UltraClip™ II 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.
Warnings:
1) The UltraClip™ II tissue marker is not recommended for use in patients with breast implants.
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) The marker must only be deployed by depressing the plunger at the proximal end of the device. Do not attempt to deploy the marker by pressing or pulling on the safety switch.
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:
Potential complications of marker placement may consist of hematoma, hemorrhage, infection, adjacent tissue injury and pain.