How Supplied; Contraindications; Potential Complications; Equipment Required - Bard MAGNUM Instructions D'utilisation

Instructions for Use
Bard ® Magnum ®
Bard Magnum Disposable Core Biopsy Needle with Spacer
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
A. General Information and Device Description:
The Bard Magnum biopsy instrument is a spring-loaded, reusable core tissue biopsy device. It has
selectable penetration depths of 22mm and 15mm. The Bard Magnum needle is a single patient use core
biopsy needle designed exclusively for use with the Bard Magnum reusable core biopsy instrument for
acquisition of core biopsy tissue samples.
B. How supplied:
• The Magnum instrument is sold nonsterile and is to be decontaminated and processed (e.g. cleaned,
lubricated, etc.) prior to use by the end-user.
• The Magnum biopsy needles are sold sterile for single patient use only and are available in various
gauge sizes and lengths.
C. Indications for Use:
The Magnum biopsy system (instrument and needles) is intended for use in obtaining biopsies from soft
tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
D. Contraindications:
Not intended for use in bone.
E. Warnings:
1. Good medical judgment should be exercised in considering biopsy on patients who are
receiving anticoagulant therapy or who have a bleeding disorder.
2. The collection of multiple needle cores may help to ensure the detection of any cancer tissue.
3. A "negative" biopsy in the presence of suspicious radiographic findings does not preclude the
presence of carcinoma.
4. Post-biopsy patient care may vary with the biopsy technique utilized and the individual
patient's physiological condition. Observation of vital signs and other precautions should be
taken to avoid and/or treat potential complications that may be associated with biopsy pro-
cedures.
5. Magnum needles are for single patient use only. Do not reuse. Do not resterilize.
F. Precautions:
1. Use only Bard Magnum biopsy needles with the Bard Magnum biopsy instrument. We cannot
recommend the use of biopsy needles made by other manufacturers.
2. This product should be used by a physician who is completely familiar with the indications, contra-
indications, limitations, typical findings and possible side effects of core needle biopsy, in particular,
those relating to the specific organ being biopsied.
3. The introduction of the needle into the body should be carried out under imaging control (ultrasound,
X-Ray, CT, etc.).
4. Never test the instrument while the needle is installed in the instrument. This could result in needle
damage and/or patient injury.
5. Unusual force applied to the stylet or unusual resistance against the stylet, while extended out of the
supportive cannula may cause the stylet to bend at the specimen notch. A bent specimen notch may
interfere with needle function.
6. Inspect the instrument for signs of deterioration or damage (cracking, blistering, separation of coating,
pitting). DO NOT USE if deterioration or damage is observed.
7. After use, the Magnum needles may be a potential biohazard. Handle and dispose of in accordance
with accepted medical practice and with applicable local laws and regulations.
G. Potential Complications:
Potential complications of core biopsy are site specific and may consist of hematoma, hemorrhage,
infection, adjacent tissue injury, and pain.
H. Equipment Required:
• Appropriate imaging modality accessories
• Surgical gloves and drapes
• Local anesthetic
• Coaxial cannula (optional)
Reusable Core Biopsy Instrument
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