Inhaltsverzeichnis - Boston Scientific IDC Gebrauchsanweisung

tabLe oF Contents
warnInG ................................................................................................................................................ 2
DevICe DesCrIptIon............................................................................................................................ 2
Figure 1. IDC Coil ......................................................................................................................... 2
Contents .............................................................................................................................................. 2
IntenDeD Use/InDICatIons For Use ............................................................................................ 2
ContraInDICatIons ........................................................................................................................... 2
warnInGs .............................................................................................................................................. 3
GeneraL preCaUtIons ...................................................................................................................... 3
MaGnetIC resonanCe IMaGInG (MrI) saFety InForMatIon .............................................. 3
Medical Registration ........................................................................................................................ 3
aDverse events .................................................................................................................................. 3
CoIL sIZe seLeCtIon ............................................................................................................................ 3
How sUppLIeD....................................................................................................................................... 3
Handling and Storage ....................................................................................................................... 3
DevICe preparatIon........................................................................................................................... 3
Figure 2. Example of Continuous Flush Setup ......................................................................... 4
DIreCtIons For Use ............................................................................................................................ 4
Figure 3. Introducer Sheath with Twist-Lock Mechanism ................................................... 4
Figure 4. Unlock via Counter-Clockwise Rotation .................................................................. 4
Figure 5. Advancing IDC Coil to Pre-Release Position (1-RO marker microcatheter) ..... 4
Figure 6. Delivering IDC™ Coil (1-RO marker microcatheter) .............................................. 5
warnInGs .............................................................................................................................................. 5
preCaUtIons......................................................................................................................................... 5
IDC CoIL reMovaL proCeDUre ........................................................................................................ 5
Figure 7. Lock via clockwise rotation ....................................................................................... 5
warranty ............................................................................................................................................. 5
Black (K) ∆E ≤5.0
IDC
™
Interlocking Detachable Coil
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
warnInG
Contents supplied STERILE using an ethylene oxide (EO) 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.
After use, dispose of product and packaging in accordance with hospital, administrative and/
or local government policy.
Do not use catheters, delivery wires or IDC Coils that have been damaged in any way.
Damaged catheters may rupture causing vessel trauma or tip detachment during steering
maneuvers. Damaged delivery wires and IDC Coils may cause vessel trauma or unpredictable
distal tip response during steering maneuvers. Take care not to puncture gloves or sterile
drapes when handling delivery wire.
DevICe DesCrIptIon
The IDC Coil includes a standard or soft coil (manufactured from platinum-tungsten alloy)
that is mechanically attached to a coil delivery wire. This assembly is contained within an
introducer sheath. The IDC Coil is designed to be delivered under fluoroscopy with a 0.53
mm (0.021 in) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with
one radiopaque (RO) tip marker. The interlocking delivery wire design allows the coil to be
advanced and retracted before final placement in the vessel, thus aiding in more controlled
delivery including the ability to withdraw the coil prior to deployment.
Delivery Wire
Microcatheter
Figure 1. IDC Coil
Contents
The IDC Coil includes an embolic coil with interlocking delivery wire and introducer sheath.
IntenDeD Use/InDICatIons For Use
The IDC Coil is a modified interlocking detachable coil indicated to obstruct or reduce rate of
blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
ContraInDICatIons
None known.
2
Interlocking Detachable Arms
IDC Coil