Medtronic 6248V-90L Technical Manual

ATTAIN SELECT™ II + SUREVALVE™

Delivery catheter system

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks
(“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a
Medtronic entity in the United States and/or in other countries.

Attain Select™, Attain™, SureValve™

Explanation of symbols

Package contents

Product documentation

Recycle

Do not use if package is damaged

Do not reuse

Sterilized using ethylene oxide

Date of manufacture

Manufacturer

Manufactured in

Use-by date

Lot number

Storage temperature limitation

Inner diameter

Outer diameter

Catalog number

Consult instructions for use at this website

Nonpyrogenic

6248V-90S delivery catheter

6248V-90 delivery catheter

6248V-90L delivery catheter

6248V-130 delivery catheter

6248V-130L delivery catheter

6248V-90SP delivery catheter

6248V-90P delivery catheter

6248V-130P delivery catheter

Inner catheter

Valve Tool

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1 Description

The Attain Select II + SureValve delivery catheter system is designed to facilitate left-heart lead
delivery to a desired cardiac vein. The delivery catheter system includes a delivery catheter and
an inner catheter, as follows:

• The delivery catheter aids in subselection and provides a pathway for the delivery of
transvenous devices such as leads, inner catheters, and guide wires. It has a radiopaque
flexible tip to facilitate viewing during fluoroscopy.

• The inner catheter supports the delivery catheter and aids in subselection. The inner catheter
has a radiopaque tip and allows delivery of a guide wire or contrast solution.

The delivery catheter system is used with an outer guide catheter, which is the sheath used to gain
coronary sinus access. Together, the catheters function as a telescoping system that can provide
additional subselecting capabilities.

1.1 Contents of package

This package contains the following components:

• 1 delivery catheter with a SureValve integrated hemostasis valve. (For a list of models and
their descriptions, see “Chapter 7”.)

• 1 inner catheter

• 2 Valve Tools

• product documentation

For illustrations of these components, see “Explanation of symbols”.

The delivery catheter system is supplied sterile. Dispose of all single-use accessories according
to local environmental requirements.

2 Indications

The Attain Select II + SureValve delivery catheter system is indicated for the delivery of contrast
medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The
delivery catheter system is indicated for use with outer guide catheters.

3 Contraindications

Use of the Attain Select II + SureValve delivery catheter system is contraindicated in patients with
obstructed or inadequate vasculature.

4 Warnings and precautions

Transvenous device compatibility – Use the delivery catheter system only with compatible

transvenous devices. Refer to the section “Chapter 7” for additional information on compatible
transvenous devices. No test data is available to demonstrate compatibility of the catheters with
any device not manufactured or distributed by Medtronic. Consequences of using the catheters
with incompatible devices may include the inability to deliver the transvenous device or damage
to the transvenous device during delivery.

Single use – The delivery catheter system is for single use only and is not intended to be
resterilized.

Sterile package inspection – Inspect the sterile package before opening it. If the package is
damaged, contact a Medtronic representative.

Storage conditions – Do not store this product above 40°C (104°F).

Expiration date – Check to verify that the product is within the expiration date. Do not use if the

product date has expired.

Sterilization – Medtronic has sterilized the package contents with ethylene oxide before
shipment.

Handling the catheters – Handle the catheters with care at all times.

• Do not kink, stretch, or severely bend the catheters.

• Do not use surgical instruments to grasp the catheter shaft.

• Do not use excessive force when inserting a catheter into a vessel.

• Ensure that the catheters are thoroughly flushed with saline or heparinized saline and free of
air before use to avoid air embolism to the patient.

• Do not allow the catheter to come into contact with liquids other than blood, saline, or contrast
solution.

Vessel and tissue damage – Use care when passing a catheter through vessels and tissue. To
minimize risk of perforation and dissection, do not push, pull, or rotate the catheter against
resistance. If resistance is met, discontinue movement, determine the reason for resistance, and
take appropriate action before continuing. Damage to the catheter may prevent it from performing
with accurate torque response and control.

Flushing the catheters – Flush the catheters through the proximal end of the catheter.

• The catheters must be thoroughly flushed and free of air before use.

• Do not use a power injection syringe to inject contrast solution.

Necessary hospital equipment – Keep external defibrillation equipment nearby for immediate
use during insertion, placement, acute lead system testing, or whenever arrhythmias are possible
or intentionally induced. Backup pacing should be readily available during implant. For
information about potential adverse events or complications, refer to the product documentation
packaged with the products chosen. Use of the catheters or transvenous devices may cause
heart block.

Thrombus formation – Thrombogenicity evaluations were conducted using a heparinized
model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus
formation may occur with this product.

5 Potential adverse events

The following are known potential adverse events associated with the use of this product.

Note: Usage of this product may result in adverse events, which may lead to injury, death, or other
serious adverse reactions.

• air embolism

• allergic reaction to contrast media

• arteriovenous fistula formation

• bleeding at the insertion site

• brachial plexus injury

• cardiac tamponade

• dislodgement

• dissection

• endocarditis

• heart block

• hematoma formation

• hemothorax

• infection

• irregular heart beat

• mediastinal widening

• perforation

• pericardial effusion

• pneumothorax

• subclavian artery puncture

• thrombophlebitis

• thrombosis

• valve damage

• vascular occlusion

• vessel damage

6 Implant procedure

Proper surgical procedures and sterile techniques are the responsibility of the medical
professional. Some implant techniques vary according to physician preference and the patient’s
anatomy or physical condition.

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When injecting fluid or aspirating during this procedure, fully insert the Valve Tool through the
SureValve integrated valve, as shown. Use this fully inserted position whether the catheter is
empty (1) or it contains a guide wire or lead (2).

Figure 1. Valve Tool in fully inserted position

Note: The SureValve integrated valve is intended to remain on the catheter throughout the

procedure. However, if necessary, it may be removed prior to the procedure by grasping the top
and bottom of the valve with a forceps, twisting the valve, and pulling it off the catheter. If removing
the SureValve integrated valve, dispose of it and do not reuse it. For instructions on using an
external valve, see the technical manual packaged with the valve.

6.1 Preparing the delivery catheter system

1. Flush the delivery catheter using the Valve Tool, as shown in the previous figure.

2. Flush the inner catheter using a syringe.

3. Insert the inner catheter into the delivery catheter.

6.2 Gaining venous access and cannulating the coronary sinus

For instructions on preparing the outer guide catheter, gaining venous access, and cannulating
the coronary sinus, refer to the technical manual packaged with an appropriate outer guide
catheter.

Note: The Attain Select II + SureValve delivery catheter system can be used to modify the outer
guide catheter curve and extend catheter reach during coronary sinus cannulation. Use the same
procedure as described in “Section 6.4”.

6.3 Obtaining a venogram

Insert a venogram balloon catheter directly through the integrated valve. For instructions on
obtaining a venogram, refer to the technical manual packaged with an appropriate venogram
balloon catheter.

6.4 Subselecting a cardiac vein

1. Advance the inner catheter until the tip extends beyond the distal end of the delivery
catheter. The inner catheter straightens the tip of the delivery catheter.

2. Insert the distal end of the delivery catheter system through the outer guide catheter and
advance it until the tip extends beyond the distal end of the outer guide catheter.

3. If required, inject contrast fluid through the inner catheter using a syringe.

4. Manipulate the delivery catheter system to select the vein.

5. Remove the inner catheter.

6.5 Inserting the lead

Notes:

• To ease insertion of transvenous devices, add fluid to the integrated valve opening.

• For instructions on using a lead, refer to the lead technical manual.

Insert the lead using one of the following 2 methods.

Method 1: Inserting a preloaded lead

1. Insert the lead directly through the integrated valve, as shown. No other insertion tool is
needed.

Figure 2. Inserting a preloaded lead

2. Insert a compatible stylet or guide wire into the lead. Do not allow the distal end to extend
past the lead tip.

Method 2: Inserting a guide wire before the lead

Insert a guide wire before the lead, using 1 of the following 3 options.

Option 1

1. Insert a lead-compatible guide wire directly through the integrated valve, as shown. Figure 3. Inserting the guide wire directly through the valve

2. Insert the lead tip over the proximal end of the guide wire.

Option 2

1. Partially insert the Valve Tool onto the catheter, so it is in one of the load positions shown in
the following figure.

Figure 4. Valve Tool in guide wire load positions

2. Insert the guide wire through the opening on the Valve Tool, as shown here in both load
positions.

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Figure 5. Guide wire opening on the Valve Tool

3. Remove the Valve Tool, as shown. Figure 6. Removing the Valve Tool from the guide wire

4. Insert the lead tip over the proximal end of the guide wire.

Option 3

Note: This method cannot be used with a stylet or any guide wire with a permanent proximal knob.

1. Remove the syringe from the Valve Tool and fully insert the Valve Tool onto the catheter.

2. Insert the guide wire into the proximal end of the Valve Tool, as shown. Figure 7. Inserting the guide wire using the Valve Tool in fully inserted position

3. Remove the Valve Tool from the catheter and from the proximal end of the guide wire.

4. Insert the lead tip over the proximal end of the guide wire.

6.6 Removing the catheter

When the lead is in final position, remove the delivery catheter using a slitter. The slitter passes
through the integrated valve. During slitting, the integrated valve remains attached to the catheter.
For instructions, refer to the technical manual provided with the slitter.

Caution: During and after slitting the catheter, handle the slit edges of the catheter carefully to
prevent lead damage.

Note: Removing the catheter may dislodge the lead. If the lead dislodges, refer to the technical
manual supplied with the lead for positioning instructions.

7 Specifications (nominal)

7.1 Specifications for delivery catheter system

Delivery catheters

Inner catheter Material: Polyether block amide

SureValve integrated
valve

Valve Tool Material: Polypropylene with SBC overmold, polycar-

Model Description Usable length

6248V-90S 90° short curved tip 65 cm (25.6 in)

6248V-90 90° curved tip 65 cm (25.6 in)
6248V-90L 90° long curved tip 65 cm (25.6 in)
6248V-130 130° curved tip 65 cm (25.6 in)

6248V-130L 130° long curved tip 65 cm (25.6 in)

6248V-90SP 90° short curved tip 57 cm (22.4 in)

6248V-90P 90° curved tip 57 cm (22.4 in)

6248V-130P 130° curved tip 57 cm (22.4 in)

Material: Polyether block amide, polyamide 12

Inner diameter: 1.9 mm (5.7 Fr, 0.075 in)

Outer diameter: 2.4 mm (7.1 Fr, 0.093 in)

Usable length: 80 cm (31.5 in)

Inner diameter: 1.00 mm (3.0 Fr, 0.040 in)

Outer diameter: 1.85 mm (5.5 Fr, 0.072 in)

Material: Polypropylene with SBC overmold

bonate

7.2 Compatible transvenous devices for the delivery and inner catheters

Inner catheter

_

0.89 mm (2.7 Fr,

0.035 in)

Leads (require cath­eter removal by slit­ting)

Other transvenous
devices

Lead body maximum
outer diameter

Lead electrode tip
maximum outer diam­eter

Device maximum
outer diameter

Delivery catheter

1.77 mm (5.3 Fr,

0.070 in) _

1.88 mm (5.6 Fr,

0.074 in)

1.85 mm (5.5 Fr,

0.072 in)

7.3 Lengths of compatible transvenous devices

Delivery catheter length

65 cm (25.6 in) 57.5 cm (22.6 in) 88 cm (34.6 in)
57 cm (22.4 in) 50 cm (19.7 in) 78 cm (30.7 in)

a

The specified lengths pertain to outer guide catheters containing a SureValve integrated valve.
If using an external valve, a shorter outer guide catheter length may be required.

Compatible outer guide
catheter maximum length

Compatible lead minimum

a

length

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8 Medtronic disclaimer of warranty

For complete disclaimer of warranty information, see the accompanying disclaimer of warranty
document.

9 Service

Medtronic employs highly trained representatives and engineers located throughout the world to
serve you and, upon request, to provide training to qualified hospital personnel in the use of
Medtronic products. Medtronic also maintains a professional staff to provide technical
consultation to product users. For more information, contact your local Medtronic representative,
or call or write Medtronic at the appropriate address or telephone number listed on the back cover.

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Medtronic, Inc.

*M731414B001*

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Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
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Tachycardia: [phone]

Technical manuals

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© 2021 Medtronic
M731414B001 AA
2021-06-23