Boston Scientific M004 9900 0 Ultra ICE Imaging Catheter, M004 9915 0 Fluid Dock Filling Device User manual

Transseptal Imaging with the Ultra ICE™ Imaging Catheter
Four Images You Need to Know.
The four ultrasound images shown below are images commonly seen when using the Boston
Scientific Ultra ICE Imaging System in a transseptal procedure. The corresponding procedural
information is reflective of how experienced physicians might typically respond when each of
these images is observed.
Anterior
Ultra ICE
Catheter Tip
AAO
Start in the SVC
Place the Ultra ICE Catheter in the Superior Vena Cava
(SVC). Typical structures visible in this plane are the
Ascending Aorta (AAO), Right Pulmonary Artery (RPA),
and the Right Superior Pulmonary Vein (RSPV).
SVC
R
L
RPA
RSPV
* View from patients feet.
Posterior
Ultra ICE
Catheter Tip
Anterior
Pull Back to the mid RA / Next to FO
AOV
Continue withdrawing into the Right Atrium (RA) until the
center of the Fossa Ovalis (FO) is clearly seen in the ICE
image. Typical structures visible in this plane are the Left
Atrium (LA), Left Atrial Free Wall (LAFW), Aortic Valve
(AOV) and the Crista Terminalis (CT).
LAFW
R
L
LA
RA
CT
FOSSA
OVALIS
Posterior
Ultra ICE
Catheter Tip
Anterior
Too Far: RA Floor
If the ICE images show the RA floor, Coronary Sinus (CS), or
Inferior Vena Cava (IVC), you have withdrawn too far and
need to reverse course.
CS
R
L
RA
Posterior
Ultra ICE
Catheter Tip
Advance Back to the proper Transseptal
Position (mid RA/FO) and position Dilator.
When the ICE image shows the center of the fossa, use
fluoro to guide the transseptal dilator to the Ultra ICE
Catheter Tip, and advance the dilator along the septal wall
until tenting of the fossa is observed on the ICE image.
Suggested Accessories for an Ultrasound Case: M004 9900 0 Ultra ICE Catheter and M004 9915 0 Fluid Dock® Filling
Device and 9F or larger (ID) sheath. Images not necessarily indicative of clinical performance. Actual images will vary.
Anterior
TENTING
(due to dilator)
AOV
R
LAFW
RA
L
LA
Posterior
SHADOW
FROM DILATOR
INTENDED USE/INDICATIONS FOR USE
The Ultra ICE™ Rounded Tip Catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
CONTRAINDICATIONS
This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization.
This device is not to be used in the coronary arteries.
This device is not intended for fetal use.
WARNINGS
• DO NOT advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.
• If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously.
• When utilizing a steerable guide sheath, it is not recommended to articulate the sheath tip beyond 55 degrees. Over articulation may result in separation and/or embolization of device components
that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• Utilizing a fixed curve guide sheath with an angle greater than 55 degrees is not recommended. This could result in separation and/or embolization of device components that could lead to vessel
obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• A guide sheath with an inner diameter less than 2.84 mm must never be utilized. Utilization of such a guide sheath could cause separation and/or embolization of device components that could lead
to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
• When utilizing the ICE catheter, it is not recommended to place the transducer assembly within the curve of the guide sheath while imaging. This could result in separation and/or embolization of
device components that could lead to vessel obstruction or necessitate percutaneous or surgical intervention. In rare cases, stroke or death could result.
PRECAUTIONS
• Contents supplied STERILE using a gamma radiation (Cobalt 60) 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.
• This device should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used.
• After the procedure, inspect the catheter carefully for any damage which may have occurred during use.
• The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Do not attempt to connect the catheter to electronic equipment
other than the designated systems.
• Never attempt to attach or detach the catheter while the motor is running. To do so may damage the connector.
• Throughout the procedure anticoagulant therapy is recommended for patients undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing
right-sided procedures.
• Avoid any sharp bends, pinching or crushing of the catheter.
• Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. An insertion angle greater than 45° is considered excessive.
• Turn the MDU “OFF” before withdrawing the imaging catheter, or when advancing the catheter in the body.
• Prior to utilizing the ICE cahteter, verify there are not kinks in either the ICE catheter or guide sheath. Utilization of a kinked ICE catheter and/or guide sheath could compromise the functionality of the
ICE catheter, leading to a device failure.
ADVERSE EVENTS
The risks and discomforts involved in imaging cardiac structures include those associated with similar types of diagnostic procedures in the heart. However, any of these risks for discomforts may occur
with greater frequency or severity than previously reported. Additionally, these complications may necessitate additional medical treatment including surgical intervention.
• Myocardial infarction
• Abnormal heart rhythms
• Thrombosis
• Hematoma
• Cardiac wall injury including perforation
• Vascular wall injury including perforation
• Infection/discomfort
• Damage to cardiac valvular structures
• Hypotension/Hypertension
• Endocarditis
• Stroke/embolism
• Death
As with all procedures that utilize the Seldinger Technique for introducing a catheter into an artery, the following complications have been reported:
• Infection and pain in the region of the insertion site
• Hemorrhage
• Arteriovenous Fistula
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. See the appropriate technical
manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions,
and potential adverse events.
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. EP-145704-AB JUN2014
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