Potential Adverse Events; Clinical Benefits - Merit Medical Arcadia Mode D'emploi

• Do not use damaged products. Prior to use, inspect the packaging and product to
verify that no damage has occurred.
• For single patient 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 Arcadia balloon catheters should only be inflated using an inflation device
such as the DiamondTOUCH™ Syringe or the StabiliT Touch™ Syringe.
• Only inf late the balloons with liquid contrast media: a 60% solution is
recommended. Follow manufacturer's instructions for contrast medium
indications, usage, warnings, precautions, and contraindications.
• Steerable balloon catheters should only be deployed in curved channels previously
created by the PowerCURVE® Navigating Osteotome to prevent balloon damage.
• Risk of balloon rupture increases if the balloon comes in contact with bone cement
when balloon volume has not been decreased by 1cc from inflated volume.
• The inflation characteristics of the balloon may be altered when inflated inside
bone.
• Use the inflation device to withdraw contrast from the balloon and deflate the
balloon completely before removal.
• If using the Arcadia steerable balloon catheter, return the steering mechanism to
the starting position by turning the steering handle counter-clockwise until the
hard stop is detected, prior to balloon catheter removal.
• Dispose of used product per local, state and federal blood borne pathogen
controls including biohazard sharps container and disposal procedures.
• In the EU, any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the applicable
Member State.

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with the use of the balloons include:
• Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary
embolism or other clinical sequelae.
• Rupture with fragmentation of the inflatable portion of the (device) resulting in
retention of a fragment within the vertebral body.
• Rupture of the balloon causing contrast medium exposure, possibly resulting in an
allergic reaction or anaphylaxis.
• Deep or superficial wound infection.
• Retropulsed vertebral body bone fragments which may cause injury to the spinal
cord or nerve roots resulting in radiculopathy, paresis or paralysis.
• Fracture of the end plate and/or sidewall of the vertebral body due to over inflation
of a nonmobile fracture.
• Re-fracture of treated vertebral body
• Bleeding or hematoma.
• Pneumothorax.
• Pedicle fracture.

CLINICAL BENEFITS

The Arcadia™ steerable and straight balloon catheters are intended to be used for the
reduction and fixation
of fractures and/or creation of a void in cancellous bone in the spine. This includes
use during percutaneous vertebral augmentation. These balloon catheters are to be
used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use
during percutaneous vertebral augmentation, such as kyphoplasty.
DIRECTIONS FOR USE
CAUTION: Follow the manufacturer's Instructions For Use for the inflation device.
CAUTION: Contrast media may have different viscosity and precipitation levels that
may cause slower inflation and deflation times. For this reason, the use of at least a
60% contrast medium is recommended.
• Select the Arcadia balloon catheter size and type based on the site and treatment
goal. Table 1 defines the inflated diameter (D) and the inflated length (L) of the
Arcadia balloon in 37°C water at 2mL and the maximum inflation volume.
• The dimensions below may vary during product use due to variation in bone
structure.
Note: All Arcadia balloon catheters are 10G compatible with a maximum inflation
pressure of 700 psi.
Balloon
Catalog #
Configuration
ARC10SB Steerable
ARC15SB Steerable
ARC20SB Steerable
ARC25SB Steerable
ARC30SB Steerable
ARC10ST Straight
ARC15ST Straight
ARC20ST Straight
ARC25ST Straight
ARC30ST Straight
Table 1: Inflated dimensions in 37°C water
Pre-Inflation
Length
10mm
15mm
20mm
25mm
30mm
10mm
15mm
20mm
25mm
30mm
Max Inflation
Volume
Volume
3cc
4cc
5cc
7cc
8cc
3cc
4cc
5cc
7cc
8cc
Diameter
(D)
2cc 14mm
3cc 16mm
2cc 14mm
4cc 17mm
2cc 13mm
5cc 18mm
2cc 13mm
7cc 19mm
2cc 13mm
8cc 20mm
2cc 14mm
3cc 16mm
2cc 14mm
4cc 17mm
2cc 13mm
5cc 18mm
2cc 13mm
7cc 19mm
2cc 13mm
8cc 20mm
Length
(L)
16mm
20mm
18mm
23mm
21mm
27mm
25mm
34mm
26mm
36mm
16mm
20mm
18mm
23mm
21mm
27mm
25mm
34mm
26mm
36mm