The UltraClip™ II Breast Tissue Markers are designed to allow a breast lesion to be marked so the site can be accurately identified at a future date. The marker family is designed for use with ultrasound, MRI or stereotactic imaging guidance.
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Marker Shapes that Celebrate Her
With each purchase of the Heart, Venus or Ring breast tissue marker shapes, BD will contribute $1 to the American Cancer Society™ in honor of breast cancer patients.*
* Applies to specially marked BD breast tissue marker products purchased from BD. The American Cancer Society™ does not endorse any service or product. Visit bd.com/icoh for details. Valid through September 30.
Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.
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UltraClip™ Breast Tissue Marker
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.
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