Adverse Events; How Supplied; Operational Instructions - Boston Scientific Expect Slimline M00555500 Instrucciones De Uso

aDverse events

Complications associated with the use of the Expect™ Slimline (SL) Needle may include:
• Bleeding
• Perforation
• Pancreatitis
• Infection
• Peritonitis
• Inflammation
• Aspiration
• Fever
• Allergic Reaction
• Hypotension
• Respiratory Depression or Arrest
• Cardiac Arrhythmia or Arrest
• Tumor Seeding
• Pain
• Fiducial Migration

How sUpplIeD

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if package
is opened or damaged. Do not use if labeling is incomplete or illegible. If damage is
found, call your Boston Scientific representative. Package contents include:
• One (1) Expect Slimline (SL) Needle
• One (1) Vacuum Syringe
• One (1) One-Way Stopcock
storage
Store in a cool, dry, dark place.

operatIonal InstrUctIons

Device selection
1. Choose appropriate size of device for the procedure.
Device selection
Sampling of submucosal and extramural
gastrointestinal lesions (fine needle aspiration)
Delivery of injectable materials (fluids)
Delivery of fiducials (luer loading)
Delivery of fiducials (loading via needle tip)
Passage of accessory devices*
*19 Ga Flexible has demonstrated to be compatible for the delivery of the Mauna Kea
Cellvizio AQ-Flex™ 19 Confocal Miniprobes™ accessory device.
Black (K) ∆E ≤5.0
19 Ga 19 Ga
22 Ga 25 Ga
flexible standard
X X X X
X X X
X X X
X X X
X
See below table for needle size by fiducial dimensions:
Maximum fiducial outer
needle size
Diameter (mm)
19 Ga Flexible and 19 Ga
22 Ga
Fiducials are not recommended for use with the 25 ga needle.
2. Inspect Boston Scientific device to ensure it is within acceptable shelf
life constraints.
product preparation
1. Open device package and remove plastic insert containing FNA device
and syringe.
2. Remove the device and syringe from the package.
caution: Visually inspect the stopcock when removed from the package to
confirm it is in the open position; otherwise, DO NOT USE IT. Call Boston
Scientific Customer Service and return the product.
caution: Visually inspect the device for loose, bent or broken parts, cracks,
or other abnormalities. Inspect the catheter for any kinks or other damage. If
an abnormality is detected, DO NOT USE. Broken parts, cracks, or kinks will
hinder the mechanical operation of the Expect Slimline (SL) Needle. If the
device fails to operate properly in any way or shows any signs of damage, DO
NOT USE IT. Call Boston Scientific Customer Service and return the product.
syringe preparation
[For following indications: Sampling of submucosal and extramural gastrointestinal
lesions (fine needle aspiration), delivery of injectable materials (fluids)]
1(a)
1(b)
figure 1.
1(a): Normal Sliding Use
1(b): Locks to Hold Vacuum
1. Examine the stopcock (Figure 1(a)). The stopcock has two luer connections
to attach to the needle and syringe. Air can be exchanged with the stopcock
in the open position. The stopcock is open when it is aligned parallel to the
syringe; it is closed when perpendicular to the syringe (as shown).
4
Maximum fiducial length (mm)
0.80 10
0.35 10
1(c): Locking Fins
1(d): Stop Pin
1(d)
1(c)