+ All Categories
Home > Documents > Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All...

Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All...

Date post: 12-Jun-2020
Category:
Upload: others
View: 0 times
Download: 0 times
Share this document with a friend
18
© 2015 Boston Scientific Corporation. All Rights Reserved 1 PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use, Please review the Interlock 18 Coil Directions For Use
Transcript
Page 1: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 1 PI-191804-AB JUL2015

Product Deployment

Slide Deck

Prior to Use, Please review the Interlock 18 Coil Directions For Use

Page 2: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 2 PI-191804-AB JUL2015

Interlock™ 18 Coil Product Deployment

Slowly withdraw the Interlock Fibered IDC Occlusion System from its dispenser coil and inspect assembly. Discard if there

is any evidence of damage.

Images Property of Boston Scientific Corporation

Page 3: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 3 PI-191804-AB JUL2015

Ensure that the Interlock Fibered IDC Occlusion System arms are interlocked inside the introducer sheath. Do not remove the Interlock Fibered IDC Occlusion System assembly from the

introducer sheath.

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 4: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 4 PI-191804-AB JUL2015

Release the Interlock Fibered IDC Occlusion System inside its introducer sheath by gently pinching the sheath on both sides of

the twist-lock mechanism and rotating proximal side counter-clockwise 2-3 rotations.

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 5: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 5 PI-191804-AB JUL2015

Attach the included RHV to the proximal luer adapter on the hub of the microcatheter.

RHV attaching to proximal luer

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 6: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 6 PI-191804-AB JUL2015

Begin continuous flow of an appropriate flush solution. In general, one drop of flush solution every 1-3 seconds from a pressure bag containing the flush solution is recommended.

Continuous Flow Setup

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 7: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 7 PI-191804-AB JUL2015

Open the thumbscrew of the RHV and carefully insert the Interlock Fibered IDC Occlusion System.

RHV Thumbscrew

Interlock Fibered IDC Occlusion System

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 8: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 8 PI-191804-AB JUL2015

Insert the Interlock Fibered IDC Occlusion System until the distal tip of the introducer sheath is firmly seated in the

microcatheter hub.

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 9: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 9 PI-191804-AB JUL2015

Tighten the RHV thumbscrew just enough to prevent retrograde flow but not so tight as to pinch the introducer sheath and inhibit forward movement of the delivery wire.

Interlock™ 18 Coil Product Deployment

Tighten RHV Thumbscrew

Images Property of Boston Scientific Corporation

Page 10: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 10 PI-191804-AB JUL2015

Transfer the Interlock™ Fibered IDC™ Occlusion Coil and delivery wire from the introducer sheath into the microcatheter

by advancing the delivery wire in a smooth, continuous manner.

Advance Delivery wire smoothly

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 11: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 11 PI-191804-AB JUL2015

Ensure that the introducer sheath remains firmly seated in the microcatheter hub to prevent premature deployment.

Firmly seated in hub

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 12: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 12 PI-191804-AB JUL2015

Gently withdraw and remove the introducer sheath from the microcatheter once the proximal end of the delivery wire is

within 10 cm of the proximal end of the sheath.

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 13: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 13 PI-191804-AB JUL2015

Do not discard the sheath in case it is necessary to remove the Interlock Fibered IDC Occlusion System prior to deployment.

Do Not Discard Sheath

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 14: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 14 PI-191804-AB JUL2015

Maneuver the Interlock Fibered IDC Occlusion System under fluoroscopy until the coil detachment zone is approximately 1 cm

proximal to the microcatheter radiopaque tip marker.

Interlock™ 18 Coil Product Deployment

Images Property of Boston Scientific Corporation

Page 15: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 15 PI-191804-AB JUL2015

If Interlock Fibered IDC Occlusion System repositioning is necessary, gently retract the Interlock Coil under fluoroscopy. If repositioning is difficult or impossible, remove and discard the

Interlock Fibered IDC Occlusion System.

Interlock™ 18 Coil Product Deployment

Gently Retract

Images Property of Boston Scientific Corporation

Page 16: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 16 PI-191804-AB JUL2015

To deploy the coil, slowly advance the delivery wire under fluoroscopy until the interlocking arms pass

microcatheter’s tip marker.

Interlock™ 18 Coil Product Deployment

Interlocking Arms

Microcatheter Tip Marker

Images Property of Boston Scientific Corporation

Page 17: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 17 PI-191804-AB JUL2015

Upon conclusion of coil deployment, carefully remove the delivery wire from the microcatheter. If multiple embolization

devices are required to achieve desired occlusion, please repeat the steps outlined previously or refer to Steps 1-9 in the Interlock

Fibered IDC Occlusion System Directions for Use.

Interlock™ 18 Coil Product Deployment

Carefully remove wire from Microcatheter

Images Property of Boston Scientific Corporation

Page 18: Product Deployment Slide Deck - Boston Scientific · 1 © 2015 Boston Scientific Corporation. All Rights Reserved PI-191804-AB JUL2015 Product Deployment Slide Deck Prior to Use,

© 2015 Boston Scientific Corporation. All Rights Reserved 18 PI-191804-AB JUL2015 PI-191804-AB JUL2015 © 2015 Boston Scientific Corporation. All Rights Reserved 18

Interlock™ Fibered IDC™ Occlusion System CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Interlock Fibered IDC Occlusion System 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. GENERAL PRECAUTIONS: Do not advance the Interlock Fibered IDC Occlusion System if it becomes lodged within the microcatheter. Determine the cause of the resistance and replace the microcatheter and coil if necessary. ADVERSE EVENTS: The complications that may result from a peripheral embolization procedure include, but are not limited to: • Complications related to catheterization (e.g., hematoma at the site of entry, vessel injury, etc.) • Death • Emboli • Foreign body reactions necessitating medical intervention • Hemorrhage • Infection necessitating medical intervention • Ischemia • Pain • Recanalization • Temporary neurological deficit • Tissue necrosis • Undesirable clot formation of the vasculature • Vasospasm Interlock and Fibered IDC are unregistered trademarks of Boston Scientific Corporation or its affiliates. 90960711 Rev AB


Recommended