Bard SenoMark UltraCor Gebrauchsanweisung

S M
®
Breast Tissue Marker
ENGLISH
Instructions for Use
GENERAL INFORMATION AND DEVICE DESCRIPTION
The S M U C
® ® Breast Tissue Marker consists of a disposable 14 gauge
ENO ARK LTRA OR
beveled needle with depth marks and a locking plunger applicator available in 10
centimeter and 13 centimeter lengths. The 10 centimeter applicators contain a
resorbable polyglycolic acid (PGA) pad with a wireform that includes an interwoven
polyvinyl alcohol (PVA) polymer for permanent ultrasound enhancement. The 13
centimeter applicators contain 3 resorbable PGA pads with a wireform in the middle
pad that includes an interwoven PVA polymer for permanent ultrasound enhancement.
The PGA pad(s) are essentially resorbed in approximately 12 weeks. Please note the
PVA polymer is not resorbed.
Product Gauge x
Code Length
SMUC10C 14g x 10cm
SMUC10H 14g x 10cm
SMUC10R 14g x 10cm
SMUC10V 14g x 10cm
SMUC13C 14g x 13cm
SMUC13H 14g x 13cm
SMUC13R 14g x 13cm
SMUC13V 14g x 13cm
The wireform is intended for long-term radiographic marking of the biopsy site. The
PVA polymer is intended for long-term sonographic marking of the biopsy site.
INDICATIONS FOR USE
The S M U C
® ®
Breast Tissue Marker is intended to radiographically and
ENO ARK LTRA OR
sonographically mark breast tissue during a percutaneous breast biopsy procedure.
CONTRAINDICATIONS
Patients with a known hypersensitivity to the materials listed in the device description
may suffer an allergic reaction to this implant.
WARNINGS
1. Use caution when placing near a breast implant to avoid puncture of the
implant capsule.
2. Do not use in the presence of infection.
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
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
mechanical changes.
U C
®
Applicator Marker
Color Material
™
BioDur 108
Pink
with PVA
Titanium
Red
with PVA
Titanium
Ice Blue
with PVA
™
BioDur 108
Violet
with PVA
BioDur ™ 108
Pink
with PVA
Titanium
Red
with PVA
Titanium
Ice Blue
with PVA
BioDur ™ 108
Violet
with PVA
PRECAUTIONS
1. This product should only be used by a physician who is completely familiar with the
of breast tissue marker placement.
2. Store in a cool, dry place.
3. Use caution when handling the device to prevent premature deployment of the
breast tissue marker.
4. Do not use if needle is bent and/or tip is damaged.
5. Ensure that all pads are dispensed.
6. 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.
POTENTIAL 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, adjacent tissue injury and pain.
EQUIPMENT REQUIRED
Marker
Shape
The following equipment is required to place the breast tissue marker:
• Appropriate imaging modality and accessories
Coil
• Surgical gloves and drapes
• Local anesthetic
Heart • Other equipment as necessary
HOW SUPPLIED
Ribbon The S M
®
ENO ARK
unless the package has been opened or damaged. Sterilized using irradiation. For
single use only. Do not reuse. Do not resterilize.
Venus
The 13 centimeter applicators are packaged with Length Adapters shown in Figure 2.
DIRECTIONS FOR USE
Coil
REFER TO FIGURES 1, 2 & 3
Heart
Ribbon
Venus
Needle (C)
Compatible Introducers
7G & 10G E
N
Introducer Models
ECMRINTLOC
ECMRINTLOC7G
7G & 12G E
N
Introducer Models
ECSTUS017G
ECSTUS0110G
ECSTUS0112G
Eviva ™ Biopsy Probe
Cannula
0913-20
1213-20
1
U C
®
Breast Tissue Marker is provided sterile and non-pyrogenic
LTRA OR
Plunger (A)
Applicator (B)
Tip Protector (D)
Figure 1
Length Adapter Used
C
® MRI MRI Length Adapter
OR
First Step for E
C
® Ultrasound Length Adapter
OR
Eviva ™ Length Adapter
Figure 2
Adapter Color
C ®
N OR
White
Black
Beige