Merit Medical OSSEOFLEX SB Gebrauchsanweisung

OSSEOFLEX
STEERABLE BALLOON AND STRAIGHT BALLOON
Device is sterile. Do not reuse and do not re-sterilize.
INDICATIONS FOR USE
The Osseoflex® SB is 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. This system is to be used with cleared spinal polymethylmethacrylate
(PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
DEVICE DESCRIPTION
The Osseoflex SB is designed for use in balloon kyphoplasty or vertebral augmentation. The inflatable bone tamp or balloon serves to create
a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The bone tamp provides a conduit
through which the physician can inflate the balloon. After the bone is disrupted, PMMA is injected through an Osseoflex® SN Steerable
Needle or an Osseoflex Bone Filler Device to fill the previously created void(s).
An access channel is required for Osseoflex SB placement. The Osseoflex SB device does not create an access channel; the Osseoflex SB is
designed to follow a pre-existing channel created by an access channel device.
If the Osseoflex SB Steerable Balloon has an articulating stylet inserted it enables the steerable feature of the balloon. The articulating or
steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex SB actuation knob
can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device
and allow the device to be returned to its start position.
The balloons should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality
images.
CONTENTS:
The device package contains (1) Osseoflex SB inflatable bone tamp (10 gauge, 2ml or 4ml balloon size).
WARNING: Sterilized with electron beam irradiation (IR). Do not use if package is opened or damaged.
WARNINGS / PRECAUTIONS
Thoroughly read the "Instructions for Use" and these warnings and precautions prior to device operation.
• Use the device prior to the "Use By" date noted on the package. Do not use this product after the expiration date printed on the
package. The device may not be safe or effective beyond its expiration date
• For safe and effective use, this device should only be used by qualified physicians with training in the clinical procedure in which
it is being used. The physician should have specific training, experience, and thorough familiarity with the use and application of
this product.
• Always use image guidance with radiographic equipment that provides high quality imaging to avoid patient injury. Use
appropriate imaging techniques to confirm correct Working Cannula placement (before and during advancement and after
removal); absence of damage to surrounding structures, and appropriate location of delivered bone cement. Imaging, such as
venography, can be used to assess the ability of the vertebra to contain the delivered bone cement.
• It is essential to maintain a strict sterile technique during the procedure and during all phases of handling this product.
• Dispose of used product per local, state and federal blood borne pathogen controls including biohazard sharps container and
disposal procedures.
• DO NOT use if package is opened or damaged. All devices are provided sterile. All devices are sterilized using gamma radiation.
These devices are intended for single use only. DO NOT re-sterilize or re-use. Reconditioning, refurbishing, repair, modification, or
re-sterilization of the device(s) to enable further use is expressly prohibited, as it may result in patient injury including loss of
function and/or infection.
• The Osseoflex SB should only be inflated using an inflation device.
• Inflating the vertebral balloon beyond the maximum inflation volume may cause the balloon to rupture before reaching the
maximum inflation pressure of 400 psi.
• Deflate the balloon before removal. Use the inflation syringe to withdraw contrast from the balloon before removal.
• If using the Osseoflex SB Steerable Balloon, return the actuation knob to the starting position by turning the knob counter-
clockwise before removal.
• Avoid contact between the balloon and the PMMA bone cement
• The balloon may rupture due to bone splinters and/or contact with instruments.
• Do not inflate the balloon until it has been fully deployed in the vertebral body. Inflating the balloon prior to full deployment may
result in premature balloon failure due to contact between the balloon and the access cannula.
• Breakage of the device may require intervention or retrieval.
• Never use any air or any gaseous medium to inflate the Osseoflex SB. Use only the recommended minimum 60% contrast
medium.
• Follow manufacturer's instructions for contrast medium indications, usage and cautions.
• Clinicians should ensure that patients have no unusual risks for bleeding or infection.
• Patients should have no evidence of active infection.
• Patients should also be free of spinal instability that in the judgment of the clinician would remain after vertebral augmentation,
and deemed safe for regional or local anesthesia as determined appropriate by the clinician.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with kyphoplasty or vertebroplasty include:
• Pneumonia
• Intercostal neuralgia
• Collapse of a vertebra adjacent to the one injected, due to an osteoporotic disease
• Pneumothorax
• Extravasation of bone cement into soft tissue
• Fracture of a pedicle
• Compression of the spinal cord with paralysis or loss of feeling
Potential adverse events potentially associated with the use of the (device) include:
• Infection, including deep or superficial wound infection.
• Unintended puncture wounds including vascular puncture and dural tear.
• 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 (device) 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.
• Bleeding or hematoma.
• Incorrect placement of the access cannula / stylet assembly or hand drill, possibly resulting in rupture of the aorta and/or nerve
damage.
• Dypsnea
• Rib fracture
• Re-fracture of treated vertebral body
• Paravertebral abscess formation
• Vertebral osteitis
• Hemorrhage
• Hematoma
• Pain
Contraindications
• Instability of posterior wall and/or pedicles
• Should not be used if vertebral dimensions or fracture pattern do not allow safe placement and inflation of the balloon
• Infection
• Severe bleeding
• Bleeding disorder or treatment that increases the chance of excessive bleeding
• Any known allergy to bone cement
• Any known allergy to contrast material
• Pregnancy
DIRECTIONS FOR USE
CAUTION: Follow the manufacturer's Instructions for Use for the inflation syringe.
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 Osseoflex SB size and type based on the site and treatment goal. Table 1 defines the inflated diameter (D) and the
inflated length (L) of the Osseoflex® SB in 37°C water at inflation volume increments to the maximum inflation volume.
403745001MLP_001_Osseoflex_SB_IFU.indd 1
®
SB
I N S T R U C T I O N S F O R U S E
Straight OT-0222 or OT-0224
-or-
Steerable OF-0222 or OF-0224
English
10/31/2017 1:11:44 PM