COOK Medical RETRACTA User manual

Retracta™ Detachable Embolization Coils
Instructions for Use
Retracta™ adskillelige emboliseringscoils
Brugsanvisning
Retracta™ ablösbare Embolisationsspiralen
Gebrauchsanweisung
Αποσπώμενα σπειράματα εμβολής Retracta™
Οδηγίες χρήσης
Espirales de embolización largables Retracta™
Instrucciones de uso
Spirales d’embolisation détachables Retracta™
Mode d’emploi
Spirali per embolizzazione a rilascio
controllato Retracta™
Istruzioni per l’uso
Retracta™ loskoppelbare embolisatiecoils
Gebruiksaanwijzing
Espirais de embolização amovíveis Retracta™
Instruções de utilização
Retracta™ löstagbara emboliseringsspiraler
Bruksanvisning
EN
9
DA
11
DE
13
EL
15
ES
18
FR
20
IT
23
NL
25
PT
28
SV
30
*T_MWCER_REV1*

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Safety Clip
2 Loading Cartridge
3 Torque Device
4 Luer Lock Adapter
1 Sikkerhedsclips
2 Ladehylster
3 Momenthåndtag
4 Luer lock-adapter
1 Sicherheitsclip
2 Ladekartusche
3 Drehgriff
4 Luer-Lock-Adapter
1 Κλιπ ασφάλισης
2 Φυσίγγιο τοποθέτησης
3 Συσκευή ροπής στρέψης
4 Προσαρμογέας ασφάλισης Luer
1 Clip de seguridad
2 Cartucho de carga
3 Dispositivo de torque
4 Adaptador Luer Lock
1 Clip de sécurité
2 Cartouche de chargement
3 Dispositif de contrôle de torque
4 Adaptateur Luer Lock
1 Clip di sicurezza
2 Dispositivo di caricamento
3 Dispositivo di torsione
4 Adattatore Luer Lock
1 Veiligheidsclip
2 Laadhuls
3 Torsie-instrument
4 Luer-Lock-adapter
1 Clipe de segurança
2 Cartucho de carregamento
3 Dispositivo de torção
4 Adaptador Luer-Lock
1 Säkerhetsklämma
2 Laddningspatron
3 Vridanordning
4 Luerlock-adapter
1
1
2
3
4

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Delivery Wire
2 Junction
3 Coil
1 Fremføringstråd
2 Forbindelsespunkt
3 Coil
1 Platzierungsdraht
2 Übergangsbereich
3 Spirale
1 Σύρμα τοποθέτησης
2 Συμβολή
3 Σπείραμα
1 Alambre de implantación
2 Unión
3 Espiral
1 Guide de largage
2 Jonction
3 Spirale
1 Spingitore
2 Giunzione
3 Spirale
1 Plaatsingsdraad
2 Overgangsgedeelte
3 Coil
1 Fio de colocação
2 União
3 Espiral
1 Införingsledare
2 Förgrening
3 Spiral
2
12
3

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
3
4
5
6

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Weaving
2 Sheath
3 Catheter
1 Snoning
2 Sheath
3 Kateter
1 Hin- und Herbewegung
2 Schleuse
3 Katheter
1 Κίνηση με ελιγμούς
2 Θηκάρι
3 Καθετήρας
1 Zigzagueo
2 Vaina
3 Catéter
1 Mouvement de va-et-vient circulaire
2 Gaine
3 Cathéter
1 Movimento alternato
2 Guaina
3 Catetere
1 Wevende beweging
2 Sheath
3 Katheter
1 Movimento circular
2 Bainha
3 Cateter
1 Vävning
2 Hylsa
3 Kateter
7
1
2 3

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Weaving
2 Sheath
3 Catheter
1 Snoning
2 Sheath
3 Kateter
1 Hin- und Herbewegung
2 Schleuse
3 Katheter
1 Κίνηση με ελιγμούς
2 Θηκάρι
3 Καθετήρας
1 Zigzagueo
2 Vaina
3 Catéter
1 Mouvement de va-et-vient circulaire
2 Gaine
3 Cathéter
1 Movimento alternato
2 Guaina
3 Catetere
1 Wevende beweging
2 Sheath
3 Katheter
1 Movimento circular
2 Bainha
3 Cateter
1 Vävning
2 Hylsa
3 Kateter
8
1
2 3

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Weaving
2 Sheath
3 Catheter
4 High radial force coil
5 High radial force coil deployed (scaffold)
6 Platinum coil (soft coil)
7 Platinum coil deployed, cross-sectional occlusion completed
1 Snoning
2 Sheath
3 Kateter
4 Coil med stor radial kraft
5 Anlagt coil med stor radial kraft (stillads)
6 Platin-coil (blød coil)
7 Anlagt platin-coil, tværsnitsokklusion gennemført
1 Hin- und Herbewegung
2 Schleuse
3 Katheter
4 Spirale mit hoher Radialkraft
5 Platzierte Spirale mit hoher Radialkraft (Gerüst)
6 Platinspirale (weich)
7 Platzierte Platinspirale, Verschluss des Querschnitts abgeschlossen
1 Κίνηση με ελιγμούς
2 Θηκάρι
3 Καθετήρας
4 Σπείραμα υψηλής ακτινικής ισχύος
5 Απελευθερωμένο σπείραμα υψηλής ακτινικής ισχύος (ικρίωμα)
6 Σπείραμα από πλατίνα (μαλακό σπείραμα)
7 Απελευθερωμένο σπείραμα από πλατίνα, με πλήρη εγκάρσια
απόφραξη
1 Zigzagueo
2 Vaina
3 Catéter
4 Espiral con fuerza radial alta
5 Espiral con fuerza radial alta desplegada (andamio)
6 Espiral de platino (espiral blanda)
7 Espiral de platino desplegada, oclusión transversal completada
9
1
2 3 4
6
1
5
7

Illustrations • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illustrazioni • Afbeeldingen • Ilustrações • Illustrationer
1 Mouvement de va-et-vient circulaire
2 Gaine
3 Cathéter
4 Spirale à force radiale élevée
5 Spirale à force radiale élevée déployée (armature)
6 Spirale en platine (spirale souple)
7 Spirale en platine déployée, occlusion transversale terminée
1 Movimento alternato
2 Guaina
3 Catetere
4 Spirale a elevata forza radiale
5 Spirale a elevata forza radiale rilasciata (impalcatura)
6 Spirale in platino (spirale morbida)
7 Spirale in platino rilasciata, occlusione della sezione trasversale comple-
tata
1 Wevende beweging
2 Sheath
3 Katheter
4 Coil met grote radiale kracht
5 Coil met grote radiale kracht (‘scaffold’) geplaatst
6 Platina coil (zachte coil)
7 Platina coil geplaatst, volledige vaatocclusie tot stand gebracht
1 Movimento circular
2 Bainha
3 Cateter
4 Espiral de elevada força radial
5 Espiral de elevada força radial libertada (técnica de apoio)
6 Espiral de platina (espiral suave)
7 Espiral de platina libertada, oclusão transversal completa
1 Vävning
2 Hylsa
3 Kateter
4 Spiral med hög radiell kraft
5 Utplacerad spiral med hög radiell kraft (stöd)
6 Platinaspiral (mjuk spiral)
7 Utplacerad platinaspiral, genomskärning, ocklusion slutförd

9
ENGLISH
RETRACTA™ DETACHABLE EMBOLIZATION COIL
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Retracta Detachable Embolization Coil is a platinum coil with spaced
synthetic fibers, and is attached to a delivery wire. (Figs. 1 & 2) The Retracta
Detachable Embolization Coil is designed to be delivered under fluoroscopy
to the target vessel. The Retracta Detachable Embolization Coil system
allows the coil to be advanced and fully repositioned before the coil is finally
deployed.
INTENDED USE
The Retracta Detachable Embolization Coil is intended for arterial and venous
embolization in the peripheral vasculature. The coil delivery system provides
safe delivery of embolization coils when correct positioning is especially
critical.
CONTRAINDICATIONS
None known
WARNINGS
• Positioningofembolizationcoilsshouldbedonewithparticularcare.
Coils should not be left too close to the inlets of arteries and should
be intermeshed with previously placed coils if possible. A minimal but
sufficient arterial blood flow should remain to hold the coils against the
previously placed coils until a solid clot ensures permanent fixation. The
purpose of these suggestions is to minimize the possibility of loose coils
becoming dislodged and obstructing a normal and essential arterial
channel.
• TheRetractaDetachableEmbolizationCoilisnotrecommendedforuse
with polyurethane catheters or catheters with sideports. If a catheter
with sideports is used, the embolus may lodge in the sideport or pass
inadvertently through it. Use of a polyurethane catheter may also result in
lodging of the embolus within the catheter.
PRECAUTIONS
• Performanangiogrampriortoembolizationtodeterminecorrectcatheter
position.
• Priortointroductionoftheembolizationcoil,flushtheangiographic
catheter with saline.
• Thisproductisintendedforusebyphysicianstrainedandexperiencedin
arterial and venous vessel embolization techniques. Standard techniques
for placement of vascular access sheaths, angiographic catheters, and wire
guides should be employed.
PRODUCT RECOMMENDATIONS
The following catheters are recommended for use with Retracta Detachable
Embolization Coil:
• HNB(R)4.0-35
• HNB(R)5.0-35
• HNB(R)5.0-38
• SCBR-5.0-38
• SCBR-4.0-38
The PTBYC-RA is recommended for use with the Retracta Detachable
Embolization Coil to perform a test injection of contrast media.
MRI INFORMATION
Nonclinical testing has demonstrated that the Retracta Detachable
Embolization Coil is MR ConditionalaccordingtoASTMF2503.Apatientwith
this coil can be scanned safely after placement under the following conditions.
• Staticmagneticfieldof3.0Teslaorless
• Maximumspatialmagneticgradientof1600Gauss/cmorless
• MaximumMRsystemreported,whole-body-averagedspecificabsorption
rate(SAR)of2.0W/kg(normaloperatingmode)for15minutesofscanning
or less (i.e., per scanning sequence)
Static Magnetic Field
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
In nonclinical testing, the Retracta Detachable Embolization Coil produced a
maximumtemperatureriseof1.1°C(scaledtoanSARof2.0W/kg)during15
minutes of MR imaging (i.e., for one scanning sequence) performed in a MR
3.0TeslaSystem(GeneralElectricExcite,HDx,Software14X.M5).
Image Artifact
MR image quality may be compromised if the area of interest is within
approximately 9 mm of the position of the Retracta Detachable Embolization
Coil, as found during non clinical testing using the sequence: T1-weighted,

10
spinechoandgradientechopulsesequenceinaMR3.0Teslasystem(General
Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize
MR imaging parameters for the presence of this metallic embolization coil.
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners:
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock,CA95382
Phone: 888-633-4298(tollfree)
209-668-3333fromoutsidetheUS
Fax: 209-669-2450
Web: www.medicalert.org
INSTRUCTIONS FOR USE
1. Perform an angiogram and measure the diameter of the vessel to be
occluded.
2. Firmly grasping the loading cartridge between thumb and forefinger,
introduce the metal end of the loading cartridge into the base of the
catheter hub. Lock the loading cartridge onto the catheter hub by turning
the Luer lock adapter clockwise. (Fig. 3)
3. Unlockthewhitesafetyclipandadvanceatleast30cmofthedelivery
wire into the catheter so that the coil is fully loaded in the catheter.
(Fig. 4)
4. Unlock the loading cartridge from the catheter hub by turning the Luer
lock adapter counter-clockwise.
5. Remove the delivery wire holder and the metal loading cartridge from
the catheter hub while holding the delivery wire stationary. Remove the
torque device and reserve it for use later in the procedure.
6. Under fluoroscopic visualization, slowly advance the delivery wire until
the entire length of the coil exits the distal end of the catheter. Ensure
that the junction remains positioned just inside the catheter tip. (Fig. 5)
NOTE: Advancing the delivery wire slowly allows the junction to be seen
more easily and reduces the risk of damaging it.
NOTE: If significant resistance is encountered during coil advancement,
do not continue advancing. Retract the delivery wire slightly, then gently
re-advance it. If there is still significant resistance, withdraw the delivery
wire from the catheter and try using a new coil with a shorter length.
NOTE: Do not turn the delivery wire counterclockwise during
advancement; the coil may be unintentionally detached.
7. Verify correct position of the coil fluoroscopically. If coil position or
placement is not satisfactory, the coil may be retracted into the catheter
and re-deployed so long as there is no significant resistance.
NOTE: It may be possible to perform a test injection of contrast media
using a Tuohy-Borst Sidearm Adaptor while the delivery wire is in the
catheter.
NOTE: If the size of the coil is not correct, gently remove the entire
delivery wire and coil. Do not use the coil again.
8. Ifthecoilpositioniscorrect,usethetorquedevicetoturnthedelivery
wirecounterclockwise8-10times,untilcoildetachmentcanbeeitherfelt
or visualized under fluoroscopy. (Fig 6)
NOTE: It is recommended that the junction remain just inside the tip of
the catheter.
NOTE: Do not advance the delivery wire after the coil is detached.
9. Gently remove the delivery wire after coil detachment.
10. AdditionalRetractaorpushablecoilsmayberequiredtoachieve
permanent occlusion of the vessel.
Coil Delivery Technique and Coil Size Selection
Long-term occlusion depends on achieving cross sectional occlusion of the
blood vessel, and coaxial catheters provide the ability to control placement
of coils and permanent occlusion. The combination of the coaxial technique
and either the anchor or scaffold technique significantly enhances stability of
coil deployment.
• Coaxialtechnique:Theuseofouterguidingsheath/catheteristhemost
important step in preventing coil elongation and uncertain long-term
occlusion.Theouterguidingsheath/catheterprovidessupport,andthe
inner catheter provides finer selective maneuvers. (Fig. 7)
• Anchortechnique:Theanchortechniqueprovidessafeanddistal
occlusion when there is a question about instability of coils. At least 2 cm
of a coil is advanced into the side branch, which is normally sacrificed.
The rest of the coil is then deployed just proximal to that side branch, and
additional coils are packed. (Fig. 8)
• Scaffoldtechnique:Thescaffoldtechniqueisusedforhigh-flowvessels
when there is concern about migration of a softer coil. A high radial force
coil is placed initially. Then, several high radial force coils or soft coils may
be packed within the scaffold. (Fig. 9)