Boston Scientific EMBLEM S-ICD User Manual
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Boston Scientific EMBLEM S-ICD User Manual

Boston Scientific EMBLEM S-ICD User Manual

Electrode delivery system
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USER'S MANUAL
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EMBLEM
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Electrode Delivery System
REF 4712

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Summary of Contents for Boston Scientific EMBLEM S-ICD

  • Page 1 USER’S MANUAL ™ EMBLEM S-ICD Electrode Delivery System REF 4712...

  • Page 3: Table Of Contents

    Surgical Preparation ......................7 Items Included in Package .....................8 Implantation ............................9 Overview..........................9 Implant the EMBLEM S-ICD Subcutaneous Electrode ............13 Connect the Subcutaneous Electrode to the Pulse Generator..........31 EMBLEM S-ICD Electrode Delivery System Diagram ..............31 EMBLEM S-ICD Electrode Delivery System Specifications............32 Definitions of Package Label Symbols...................33...

  • Page 5: Description

    DESCRIPTION The EMBLEM S-ICD Electrode Delivery System (the "EDS") is a component of the Boston Scientific S-ICD System, which is prescribed for patients when cardiac arrhythmia management is warranted. The EDS consists of two tunneling tools with pre-loaded introducer sheaths and is used to create subcutaneous tunnels to facilitate implantation of the EMBLEM S-ICD Subcutaneous Electrode.

  • Page 6: Warnings

    Component compatibility. All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific or Cameron Health S-ICD System only. Connection of any S-ICD System components to a non-compatible component has not been tested and could result in failure to deliver life- saving defibrillation therapy.
  • Page 7 • Do not damage components. Do not modify, cut, kink, crush, stretch, or otherwise damage any component of the S-ICD System. Impairment to the S-ICD System may result in an inappropriate shock or failure to deliver therapy to the patient. •...

  • Page 8: Precautions

    Implantation • Creating the subcutaneous tunnels. Use Boston Scientific tools and accessories designed for use in implanting the subcutaneous electrode to create the subcutaneous tunnels when implanting and positioning the subcutaneous electrode. Avoid tunneling close to any other subcutaneously implanted medical devices or components, for example, an implantable insulin pump, drug pump, sternal wiring from previous sternotomy, or ventricular assist device.

  • Page 9: Potential Adverse Events

    • Suture location. Suture only those areas indicated in the implant instructions. • Do not suture directly over subcutaneous electrode body. Do not suture directly over the subcutaneous electrode body, as this may cause structural damage. Use the suture sleeve to prevent subcutaneous electrode movement.
  • Page 10 • Discomfort or prolonged healing of incision • Electrode deformation and/or breakage • Electrode insulation failure • Erosion/extrusion • Failure to deliver therapy • Fever • Hematoma/seroma • Hemothorax • Improper electrode connection to the device • Inability to communicate with the device •...

  • Page 11: Pre-Implant Information

    • Post-shock/post-pace discomfort • Premature battery depletion • Random component failures • Stroke • Subcutaneous emphysema • Surgical revision or replacement of the system • Syncope • Tissue redness, irritation, numbness or necrosis If any adverse events occur, invasive corrective action and/or S-ICD System modification or removal may be required.

  • Page 12: Items Included In Package

    The S-ICD System is designed to be positioned using anatomical landmarks. However, it is recommended to review a pre-implant chest x-ray in order to confirm that a patient does not have notably atypical anatomy (e.g., dextrocardia). Consider marking the intended position of the implanted system components and/or incisions prior to the procedure, utilizing anatomical landmarks or fluoroscopy as a guide.

  • Page 13: Implantation

    IMPLANTATION Overview This section presents the information necessary for implanting the EMBLEM S-ICD Subcutaneous Electrode (Model 3401 or 3501) using the EMBLEM S-ICD Electrode Delivery System (the “EDS”). WARNING: All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific or Cameron Health S-ICD System only.
  • Page 14 Figure 1. Placement of the S-ICD System (Model 3501 Electrode shown)
  • Page 15 [1] Skin, [2] Hypodermal layer, [3] Adipose tissue, [4] Deep fascia, [5] Sub-fascial tissue (muscle or bone), [6] Correct location for subcutaneous tunnels and the S-ICD Subcutaneous Electrode Figure 2. Subcutaneous Tissue Layers...
  • Page 16 Placement of the pulse generator and electrode can be achieved using various techniques. To ensure optimal placement of the subcutaneous electrode at the fascial plane, physician preference and patient assessment should be considered when choosing the implant method. Care should be taken to position both the electrode and device directly on the fascia without underlying adipose tissue.

  • Page 17: Implant The Emblem S-Icd Subcutaneous Electrode

    Implant the EMBLEM S-ICD Subcutaneous Electrode The following detailed instructions describe two techniques for implanting the electrode: the two-incision technique and the three-incision technique. Alternate surgical approaches could be considered if system placement requirements can be achieved. The physician determines which tools and surgical technique are used to implant and position the electrode based on the patient’s anatomical features.
  • Page 18 METHOD 1: TWO-INCISION TECHNIQUE (ANCHORING ELECTRODE AT XIPHOID INCISION ONLY) This method of implanting the S-ICD subcutaneous electrode includes the pocket incision and an incision for the electrode at the xiphoid process. It utilizes two tunneling tools of different lengths, both with pre-loaded sheaths that are used to facilitate pushing the electrode through the subcutaneous tunnels.
  • Page 19 [1] Pocket incision, [2] Xiphoid incision, [3] Lateral tunnel, [4] Superior position or incision, [5] Superior tunnel Figure 4. Electrode Implant Schematic...
  • Page 20 Lateral Tunnel Make a small, 2 cm horizontal incision at the xiphoid process (xiphoid incision). The size and orientation may vary at the physician’s discretion based on the patient’s body habitus. NOTE: If desired, in order to facilitate attachment of the suture sleeve to the fascia following electrode placement, two suture ties to the fascia can be placed at the xiphoid incision prior to continuing.
  • Page 21 [Top] Creating the lateral tunnel, [Middle] Passing the electrode from the pocket to the xiphoid incision through the sheath, [Bottom] Removing the sheath, leaving the electrode in place Figure 5. Lateral Tunnel...
  • Page 22 CAUTION: Use Boston Scientific tools and accessories designed for use in implanting the subcutaneous electrode to create the subcutaneous tunnels when implanting and positioning the subcutaneous electrode. Avoid tunneling close to any other subcutaneously implanted medical devices or components, for example, an implantable insulin pump, drug pump, sternal wiring from previous sternotomy, or ventricular assist device.
  • Page 23 OPTIONAL: If the accessory slit suture sleeve is needed in addition to the integrated suture sleeve, attach it to the electrode body as follows: Place the suture sleeve over the electrode shaft, making sure not to cover the integrated suture sleeve, sensing electrodes, or defibrillation coil. Using the preformed grooves, bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture material.
  • Page 24 Figure 6. Anchoring Subcutaneous Electrode at Xiphoid Incision...
  • Page 25 Superior Tunnel Using the superior (shorter) tunneling tool, verify the locking collar is securely fastened to the pre-loaded sheath. NOTE: Over-rotation of the locking collar will release the sheath from the tunneling handle. CAUTION: Ensure the superior tunnel is long enough to accommodate the portion of the electrode from the distal tip to the suture sleeve without buckling or curving of the defibrillation coil.
  • Page 26 [Left] Creating the superior tunnel, [Middle] Passing the electrode into the sheath after the tunneling tool has been removed, [Right] Peeling the sheath to remove it from the tunnel, while stabilizing the electrode, leaving the electrode in place. The dotted line represents the sternal midline. Figure 7.
  • Page 27 Disengage the sheath from the locking collar by turning the collar counter-clockwise. Remove the tunneling tool from the sheath while applying forward pressure to the hub of the sheath to stabilize it in the tunnel. Crack the hub of the sheath. Starting at the xiphoid incision, advance the distal tip of the electrode through the sheath until the distal sensing electrode reaches the superior position.
  • Page 28 CAUTION: Use Boston Scientific tools and accessories designed for use in implanting the subcutaneous electrode to create the subcutaneous tunnels when implanting and positioning the subcutaneous electrode. Avoid tunneling close to any other subcutaneously implanted medical devices or components, for example, an implantable insulin pump, drug pump, sternal wiring from previous sternotomy, or ventricular assist device.
  • Page 29 Figure 8. Connecting the Electrode to the Lateral Tunneling Tool With the subcutaneous electrode attached, carefully pull the tunneling tool back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges. If using S-ICD Subcutaneous Electrode Model 3501, a suture sleeve is permanently affixed (integrated) to the electrode body.
  • Page 30 cover the integrated suture sleeve, sensing electrodes, or defibrillation coil. Using the preformed grooves, bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture material. After the suture sleeve is attached to the electrode body, check that it is stable by grasping the suture sleeve with fingers and trying to slide it along the subcutaneous electrode body in either direction.
  • Page 31 Insert the distal tip of the lateral (longer) tunneling tool with the electrode still attached into the xiphoid incision between the adipose and fascial plane and tunnel subcutaneously towards the superior incision, staying below adipose tissue and as close to the deep fascia as possible (Figure 9 Tunneling to Superior Incision on page 28).
  • Page 32 Figure 9. Tunneling to Superior Incision Once the distal tip of the tunneling tool emerges from the superior incision, disconnect and retain the suture loop from the distal tip of the tunneling tool. Secure the ends of the suture with a surgical clamp. Remove the tunneling tool.
  • Page 33 Anchoring the Electrode at the Xiphoid Incision At the xiphoid incision, anchor the subcutaneous electrode to the fascia using 2-0 silk or similar non- absorbable suture material. If using S-ICD Subcutaneous Electrode Model 3501, use at least two of the four suture grooves when anchoring the electrode to the fascia.
  • Page 34 Figure 10. Anchoring the Distal Tip of the Subcutaneous Electrode NOTE: Ensure that the suture is securely fastened to fascia by gently tugging on the suture prior to tying to the subcutaneous electrode anchoring hole. Gently tug the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to the fascia.

  • Page 35: Connect The Subcutaneous Electrode To The Pulse Generator

    Additional information on post-implant follow-up and explant of the system can also be found in the applicable S-ICD pulse generator user’s manual. EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM DIAGRAM [1] Handle, [2] Locking Collar, [3] Hub, [4] Distal Tip, [5] Suture hole, [6] Picture marking for Lateral Tunneling Tool, [7] Picture marking for Superior Tunneling Tool Figure 11.

  • Page 36: Emblem S-Icd Electrode Delivery System Specifications

    EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM SPECIFICATIONS Table 1. Specifications (Nominal) Component Specifications Tunneling Tools Materials • Acrylonitrile-butadiene-styrene (ABS) • Stainless steel • Polypropylene Sheaths (pre-loaded) Materials • Polytetraflouroethylene (PTFE) • Polymethylpentene (TPX™) Lateral Tunneling Tool Length 39.2 cm Lateral Sheath Length 25.7 cm...

  • Page 37: Definitions Of Package Label Symbols

    Table 1. Specifications (Nominal) (continued) Component Specifications Sheath Size: Sheath Tip Inner Diameter 3.84 mm (11 Fr) Transportation, Handling, and Storage Temperature -18°C to +55°C (0°F to +131°F) Range TPX is a trademark of Mitsui Chemicals America, Inc. DEFINITIONS OF PACKAGE LABEL SYMBOLS The following symbols may be used on packaging and labeling.
  • Page 38 Table 2. Packaging Symbols (continued) Symbol Description Use by Lot number Reference number Temperature limitation Open here Consult instructions for use on this website: www. bostonscientific-elabeling.com...

  • Page 39: Warranty Disclaimer

    Australian Sponsor Address WARRANTY DISCLAIMER Except as otherwise provided herein, Boston Scientific disclaims all express and implied warranties for this product, including without limitation any implied warranties of merchantability or fitness for a particular purpose.
  • Page 40 Boston Scientific’s obligations under any warranty provided herein shall be limited strictly to replacement of the product. Buyer assumes all risk of loss or damages arising from use of this product.
  • Page 44 © 2017 Boston Scientific Corporation or its affiliates. All rights reserved. Boston Scientific Corporation 360210-001 EN Europe 2017-08 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA Guidant Europe NV/SA; Boston Scientific Green Square, Lambroekstraat 5D 1831 Diegem, Belgium Boston Scientific (Australia) Pty Ltd...

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