Indications For Use; Device Description - Merit Medical Vitale VITB08 Instrucciones De Uso

O c c l u s i o n B a l l o o n C a t h e t e r
I N S T R U C T I O N S F O R U S E

1. DEVICE DESCRIPTION

The Occlusion Balloon Catheter is designed for temporar y
occlusion of large vessels, including the superior vena cava
(SVC). The catheter may be used for perioperative occlusion and
emergency control of hemorrhage associated with vascular tears
that may occur during Lead Extraction procedures.
The Occlusion Balloon Catheter is an over-the-wire (OTW) tri-
lumen catheter with a compliant polyurethane balloon having
a maximum diameter of 32mm at 60cc. Two lumens inflate and
deflate the balloon while one lumen is reserved for guidewire
passage. The catheter has a usable length of 90 cm.
This device is designed to accommodate a 0.035" diameter
guidewire. Three (3) radiopaque marker bands are placed within
the balloon to facilitate balloon placement prior to inflation.
The catheter is available in two (2) sizes; each compatible with
different sized introducer sheaths as outlined in the table below.
The catheter has an extension tube with a stopcock in order to
facilitate handling and fluid control. The device model information
is outlined below:
Minimum
Introducer
Catalogue Sheath
Number Diameter
VITB08 8 Fr
VITB10 10 Fr
1.26in [32mm]
Maximum Balloon Diameter
80mm
90cm
There are risks involved with any medical procedure. Both physician
and patient should fully understand those risks associated with
surgery, and additional new risks associated specifically with the
use of this endoluminal device.
CAUTION: This device is intended for use by interventionalists
and endovascular specialists who are familiar with the
complications, side effects, and dangers associated with using
this device.
CAUTION: Read the entire Instructions for Use manual prior to
using the device.
Page 2 of 72
English
Maximum
Outer Diameter
(Crossing
Profile)
2.67mm (0.105")
3.33mm (0.131")

2. INDICATIONS FOR USE

The occlusion balloon catheter is indicated for temporary occlusion
of large vessels, including the superior vena cava, in applications
including perioperative occlusion and emergency control of
hemorrhage.
3. CONTRAINDICATIONS
The Occlusion Balloon Catheter is contraindicated in patients who:
• Are contraindicated to contrast media or anticoagulants
• Have an vascular entry site that cannot accommodate the
required introducer sheath
• Are minors <18 years old
• Are pregnant
4. WARNINGS
• The Occlusion Balloon Catheter is supplied STERILE and for
single use only. Do not reprocess or re-sterilize. Reprocessing
and re-sterilizing could increase the risk of patient infection
and of compromised device performance.
• The catheter should only be manipulated and inflated/deflated
while observing under fluoroscopy.
• If resistance is encountered at any time during the insertion
procedure, do not force passage or torque the catheter.
Resistance may cause damage to device or vessel. Carefully
withdraw the catheter.
• Do not torque or twist the catheter during insertion or
withdrawal.
• The catheter should only be advanced or withdrawn over a
guidewire.
• Maintain guidewire position throughout the procedure; do not
remove the guidewire while the balloon is inflated.
• Adhere to balloon inflation parameters outlined in the Balloon
Compliance Chart (Table 1). Do not exceed a balloon
diameter of 32mm and do not exceed 60cc inflation volume at
32mm balloon diameter. Rupture of balloon may occur. Over-
inflation may result in damage to vessel wall, vessel rupture,
balloon rupture or introduction of air emboli.
• Balloon rupture may occur under certain anatomical,
procedural, and/or clinical circumstances. It is therefore
recommended to have back-up Occlusion Balloon Catheters
on hand.
.035in 0.89mm
Maximum Guidewire Diameter
• Ensure that the balloon is fully deflated (under vacuum) before
moving the Occlusion Balloon Catheter.
• Studies indicate that the danger of micro-embolization
increases with increased manipulation and/or duration of the
procedure.
• Over inflation of the balloon can cause vessel rupture. Care
should be taken when inflating the balloon in vessels,
particularly in calcified, stenotic, and/or otherwise diseased
vessels.
• Do not use in the heart or coronary arteries.
• Hand injections using a 60cc syringe are recommended. Do
not use a pressure inflation device for balloon inflation.
• Do not use a power injector for injection of contrast medium
through distal catheter lumen. Rupture may occur.
Document Part Number: 3116-001, Rev 01 (05/2019)
QXMédical, LLC