Medtronic 6250VS Technical Manual

ATTAIN COMMAND™ + SUREVALVE™ 6250VS, 6250VC

Left-heart delivery 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 Command™, Attain™, SureValve™

Explanation of symbols

Refer to the package label to see which symbols apply to this product.

Date of manufacture

Manufacturer

Use-by date

Lot number

Sterilized using ethylene oxide

Do not reuse

Storage temperature limitation

Open here

Recycle

Manufactured in

Catalog number

Do not use if package is damaged

Consult instructions for use at this website

Outer diameter

Inner diameter

Package contents

Product documentation

Nonpyrogenic

Guidewire

6250V-45S outer guide catheter

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6250V-50S outer guide catheter

6250V-MB2 outer guide catheter

6250V-MPX outer guide catheter

6250V-EH outer guide catheter

6250V-MB2X outer guide catheter

6250V-MPX outer guide catheter

Guide-catheter dilator

Valve Tool

Slitter

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1 Description

The Attain Command + SureValve 6250VC and 6250VS left-heart delivery system kits are designed to facilitate lead
implantation in the left heart via the coronary sinus.

1.1 Contents of package

This package contains the following components:

• combination (2) of the outer guide catheters with SureValve integrated hemostasis valves that are listed in “Chapter 8”

• 1 guide wire

• 1 guide-catheter dilator

• 2 Valve Tools

• 1 slitter

• product documentation

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

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

2 Indications

The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the
coronary sinus.

3 Contraindications

If the patient has obstructed or inadequate vasculature, for either venous access or in the coronary sinus, the left-heart
delivery system is contraindicated.

4 Warnings and precautions

Transvenous device compatibility – Use the left-heart delivery system only with compatible transvenous devices. Refer

to the “Chapter 8” for additional information on compatible transvenous devices. No test data is available to demonstrate
compatibility of the catheters with any device that is 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 left-heart delivery 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.

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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.

Perforation – Due to the relative stiffness of the catheter, damage to the walls of the vessels may include perforations or
dissections. When in the right chamber of the heart, the guide-catheter dilator must be retracted within the outer guide
catheter tip to minimize the risk of perforation.

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.

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 outer guide catheter system

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

2. Flush the guide-catheter dilator using a syringe.

3. Insert the guide-catheter dilator through the integrated valve and into the outer guide catheter. Advance the
guide-catheter dilator until the distal end extends beyond the distal end of the outer guide catheter.

Note: A steerable catheter may be used in place of a guide-catheter dilator. For compatibility information, see Chapter 8.

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6.2 Gaining venous access

Gain venous access using a preferred method based on professional experience. If using an introducer sheath, refer to its
technical manual for instructions.

6.3 Inserting the outer guide catheter assembly and accessing the coronary sinus

6.3.1 Using a fixed-shape outer guide catheter

1. Place the outer guide catheter (with the guide-catheter dilator inserted) over the guide wire and through the access site.
Ensure that the guide wire is extended beyond the distal end of the outer guide catheter assembly.

2. Advance the outer guide catheter assembly. When it enters the right atrium, retract the guide-catheter dilator within the
outer guide catheter.

3. Remove the guide-catheter dilator from the outer guide catheter assembly to allow the catheter tip to resume the
pre-formed shape.

4. Manipulate the outer guide catheter to obtain coronary sinus access, using fluoroscopy to facilitate placement.

5. Advance the outer guide catheter into the coronary sinus and remove the guide wire.

6.3.2 Using a straight outer guide catheter

1. Place the outer guide catheter (with the steerable catheter inserted) through the access site.

2. Advance the steerable catheter to the right atrium.

3. Manipulate the steerable catheter to obtain coronary sinus access, using fluoroscopy to facilitate placement.

4. Advance the outer guide catheter into the coronary sinus and remove the steerable catheter.

6.4 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.

6.5 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 3 methods.

6.5.1 Method 1: Inserting a preloaded lead

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

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

Figure 2. Inserting a preloaded lead

6.5.2 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.

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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. Figure 5. Guide wire opening on the Valve Tool

3. Remove the Valve Tool, as shown.

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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.

6.5.3 Method 3: Inserting a transvenous catheter before the lead

For detailed instructions on using a transvenous catheter, refer to the appropriate technical manual.

1. Insert a transvenous catheter directly through the integrated valve to gain access to the target site.

2. If desired, advance the outer guide catheter over the transvenous catheter to the target site.

3. If the transvenous catheter is not compatible with the lead, remove it from the outer guide catheter, while maintaining
the placement of the outer guide catheter.

4. Insert the lead.

6.6 Removing the catheter

When the lead is in final position, remove the outer guide catheter using a slitter. The slitter passes through the integrated
valve. During slitting, the integrated valve remains attached to the catheter. For instructions, see Chapter 7.

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.

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7 Slitting instructions

7.1 6230UNI slitter

Figure 8.

Figure 9.

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Figure 10.

Figure 11.

11

Figure 12.

7.2 6232ADJ slitter

Figure 13.

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Figure 14.

Figure 15.

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Figure 16.

Figure 17.

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8 Specifications (nominal)

8.1 Specifications for outer guide catheters

Material (all models): Polyether block amide, polyamide 12
Inner diameter (all models): 2.4 mm (7.2 Fr, 0.095 in) minimum
SureValve integrated valve material: Polypropylene with SBC overmold

Model Description Usable length Maximum outer diameter

6250V-MB2 Multipurpose bend 2 45 cm 3.0 mm (9.0 Fr, 0.118 in)

(17.7 in)

6250V-45S Straight

6250V-EH Extended hook
6250V-MP Multipurpose 50 cm 3.0 mm (9.0 Fr, 0.118 in)

6250V-50S Straight
6250V-MB2X MB2 extra 50 cm

6250V-MPX Multipurpose extra Distal: 2.8 mm (8.5 Fr,

8.2 Specifications for accessories and compatible transvenous devices

45 cm Proximal: 3.0 mm (9.0 Fr,

0.118 in)

(17.7 in) Distal: 2.8 mm (8.5 Fr,

0.112 in)

(19.7 in)

(19.7 in) Proximal: 3.0 mm (9.0 Fr,

0.118 in)

0.112 in)

Guide wire

Valve Tool Material: Polypropylene with SBC overmold, pol-

Guide-catheter dilator Material: Polyethylene

Slitter Compatible lead diameter: 1.3 mm (4 Fr; 0.052 in) to 2 mm (6 Fr;

Compatible leads Diameter: 2.1 mm (6.2 Fr; 0.081 in) maximum
Compatible transvenous devices Diameter: 2.4 mm (7.1 Fr; 0.093 in) maximum

Material: Stainless steel

Length: 120 cm

Diameter 0.9 mm (0.035 in)

ycarbonate

Inner diameter 0.96 mm (2.8 Fr, 0.038 in) minimum

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

Usable length: 59.4 cm (23.4 in)

0.079 in)

9 Medtronic disclaimer of warranty

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

10 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.

*M731417B001*

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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)
Bradycardia: [phone]
Tachycardia: [phone]

Technical manuals

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© 2021 Medtronic
M731417B001 AA
2021-07-06