Warning; Device Description; Needle Specifications; Intended Use/Indications For Use - Boston Scientific Expect Slimline M00555500 Instrucciones De Uso

Expect ™ Slimline (SL)
Endoscopic Ultrasound Aspiration Needle
Expect ™ Slimline (SL)
f l e x i b l e
Endoscopic Ultrasound Aspiration Needle
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of
a physician.

warnInG

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to
device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
The needle tip is sharp. Take precautions to ensure that the needle is handled properly.
The needle should be treated as infectious material and could create an infection risk.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.

DevIce DescrIptIon

The Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle is an
endoscopic ultrasound aspiration needle that can be coupled to the biopsy
channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer
connection and delivered into the digestive tract. The device sheath length can be
adjusted to accommodate different model echoendoscopes.
The needle is used to acquire aspiration samples from lesions and provide therapy
within and adjacent to the digestive system's major lumens that can be identified
and targeted using the echoendoscope. Both the sheath and needle length
can be adjusted based on distance to the target lesion. The sheath and needle
length adjustments are set and locked by the physician by using the locking knob
mechanisms on the handle of the device.
An aspiration sample is obtained by penetrating the lesion with the needle while
applying suction and manipulating the needle in a back and forth motion to
aspirate cytology samples into the needle. The sample can be prepared per normal
institutional protocol.
The Expect Slimline (SL) Needle has echogenic (visible under ultrasound) features
at the distal end to facilitate real time visualization of the device under ultrasound.

neeDle specIfIcatIons

Working Length: 137.5 cm to 141.5 cm adjustable
Needle Length: 0 cm to 8 cm adjustable
Diameter: Three different needle sizes - 19 gauge, 22 gauge, and 25 gauge
M00555500 19 gauge OD: 1.10 mm
M00555510 22 gauge OD: 0.72 mm
M00555520 25 gauge OD: 0.52 mm
M00555530 19 gauge flexible OD: 1.14 mm

IntenDeD Use/InDIcatIons for Use

The Expect Slimline (SL) Needle is designed to sample targeted submucosal and
extramural gastrointestinal lesions through the accessory channel of a curvilinear
echoendoscope. It can also be used for delivery of injectable materials (fluids) or
fiducials into tissue or for passage of accessory devices.

contraInDIcatIons

Contraindications for this device are those specific to the primary endoscopic
procedure to be performed in gaining access to the desired site. Relative
contraindications to submucosal and extramural aspiration include, but are not
limited to: coagulopathy.

warnInGs

The Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle should only
be used to sample tissue where possible hemorrhage will not present a danger
to patients. The device should be used with caution and only after careful
consideration in patients with elevated bleeding times or coagulopathies.
Not for use in the heart or vascular system.

precaUtIons

Read the entire directions for use before using the Expect Slimline (SL) Needle
as well as the directions for use supplied by the manufacturers of injectable
materials (fluids), fiducials, and accessory devices, if used. The Expect Slimline
(SL) Needle should only be used by or under the supervision of physicians
trained in Endoscopic Ultrasound procedures and Fine Needle Aspiration. A
thorough understanding of the technical principles, clinical applications and risks
associated with these procedures are necessary before using this device.
The packaging and the device should be inspected prior to use. Do not use the
device if the product or packaging is damaged.
When targeting multiple sites, replace device for each site. Use of the device for
multiple sites has not been established.
Do not use the same device to perform multiple indications. Use of the device for
multiple indications has not been established.
3
Minimum 2.8 mm
Working Channel
Minimum 2.4 mm
Working Channel
Minimum 2.4 mm
Working Channel
Minimum 2.8 mm
Working Channel
Black (K) ∆E ≤5.0