BARD Biopsy STARCHMARK STMKMT11GSS Gebrauchsanweisungen

For Use with 11 Gauge Mammotome
ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
Device Description
The S M ® Breast Tissue Marker is a sterile, disposable Applicator
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containing 6 resorbable polysaccharide (starch) pellets, 1 polylactic/
polyglycolic acid-based copolymer (PLA/PGA) pellet with an embedded
radiopaque wireform, and a polyethylene glycol push pellet.
Table 1. Product Information
Product Code Wireform Material
STMKMT11GSS 316L Stainless Steel
The wireform is intended for long-term radiographic marking of the biopsy
control and management of bleeding. The pellets are essentially resorbed
in approximately 2 weeks.
biopsy cavity. Pellets are deployed from the Applicator through the biopsy
device into the biopsy cavity.
Indications For Use
The S M ® Breast Tissue Marker is intended to radiographically
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mark breast tissue during a percutaneous breast biopsy procedure.
Contraindications
Do not use this device in patients with a known hypersensitivity to the
materials listed in the device description as they may suffer an allergic
reaction to this implant.
Warnings
• This device is not recommended for use in patients with breast implants.
• Do not use in the presence of infection.
• Avoid the use of excessive force during removal of the Applicator to
prevent breakage of the Applicator tip.
• 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,
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.
• 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
• Patients with a known hypersensitivity to the materials listed in the
device description may suffer an allergic reaction to this implant.
• 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
• This device should only be used by physicians trained in percutaneous
biopsy procedures.
• Do not use if the product sterile barrier system or its packaging is
compromised.
• Maintain correct alignment of the Yellow Indicator Key (C) with the white
arrow of the biopsy probe when dispensing pellets.
• Ensure all pellets are dispensed.
™ Biopsy Probe
Wireform Shape Probe Compatibility
11G Mammotome
Mammotome ™ to access the
• Published studies with comparably sized 316L stainless steel biopsy
• 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.
• Do not use if Temperature Indicator is black.
• Although starch (polysaccharide) has known hemostatic properties,
the user should continue to employ standard methods for obtaining
hemostasis following the biopsy procedure.
Potential Complications
Potential complications may include, but are not limited to hematoma,
hemorrhage, infection, adjacent tissue injury, pain, allergic reaction,
and migration.
How Supplied / Stored
• This product is provided sterile and is intended for single use only. Do
not resterilize.
• Store at temperatures below 25° C (77° F). Do not use if Temperature
Indicator is black.
Equipment Required
The following equipment is required to place the breast tissue marker:
™
• Appropriate imaging modality and accessories
• Appropriate biopsy probe and system (see Table 1)
• Surgical gloves and drapes
• Local anesthetic
• Other equipment as necessary
Directions for Use
Refer to Figures 1 and 2.
B
A
Figure 1. S
1. Perform a "dry tap" to ensure that the sample notch is clear of tissue.
2. Using standard aseptic technique, remove the Applicator from the
package and inspect for damage. Remove tip cover.
3. Insert the Applicator into the biopsy device. Advance the Applicator
to align the Yellow Indicator Key (C) with the white arrow on the
thumbwheel of the biopsy probe. Refer to Figure 2.
Figure 2. Applicator alignment in Probe
4. Fully seat the Applicator in the biopsy probe. Verify proper alignment
of the Applicator Aperture (D) with the biopsy chamber by ensuring
proper alignment of the Yellow Indicator Key (C) with the white arrow
on the thumbwheel of the biopsy probe (Figure 2).
5. Immediately deploy all pellets by advancing the Plunger (A).
Note: Avoid pulling the Applicator Handle (B) during deployment which
could cause deployment failure.
6. Rotate the biopsy device cannula 180° to position the sample chamber
away from the dispensed pellets.
7. Remove the Applicator from the biopsy device.
Caution: If resistance is felt while removing the Applicator, remove
the entire probe/Applicator assembly from the patient. Failure to do so
may result in breakage of the Applicator tip.
8. Close the sample chamber and remove the biopsy device, per
manufacturer's instructions.
1
A. Plunger
B. Handle
C. Yellow Indicator Key
D. Applicator Aperture
C
M Breast Tissue Marker
®
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D