Medtronic 3655P38 Technical Manual

3655P38

3655 Tunneling Tool Accessory Kit (38 cm)

Instructions for Use

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

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Medtronic

Explanation of symbols on package labeling

Consult instructions for use

Date of manufacture

Do not reuse

Do not use if package is damaged

Lot number

Sterilized using ethylene oxide

Temperature limitation

Use by

Reorder number

1 Description

The Medtronic Model 3655 Tunneling Tool Accessory Kit is used by the implanting clinician to assist in subcutaneous passage of catheters between the implantable therapy delivery device pocket and the therapy access site.

2 Package contents

• 1 Handle with thumbscrew

• 1 Tunneling tool shaft

• 1 Blunt tip obturator

• 1 Cone tip obturator

• 1 Wedge tip obturator

• Product literature

3 Indications for use

The Model 3655 Tunneling Tool Accessory Kit is intended to be used to facilitate the subcutaneous passage of catheters with an outer diameter between 13.0 Fr ±

0.8 Fr.

4 Contraindications

There are no known contraindications to the use of the tunneling tool kit.

The surgical procedure to implant the catheter may be contraindicated for some patients.

5 Device specifications

The tunneling tool accessory kit includes a handle, a shaft, and 3 different shaped obturators (Figure 1).

Figure 1. Model 3655 Tunneling Tool Accessory Kit

1 Handle with thumbscrew 2 Shaft 3 Obturator 4 Obturator tips

Table 1. Device specifications for the tunneling tool shaft Description Model 3655

Shaft usable length 38 cm Inner diameter of shaft 4.9 mm maximum

5 Cone tip 6 Wedge tip 7 Blunt tip

Table 2. Materials for the Model 3655 Tunneling Tool Accessory Kit

Materials contacts

Component Material

Handle with thumbscrew Stainless steel and poly-

propylene Shaft Stainless steel Yes Obturators Polypropylene Yes

human tissue

Yes

6 Warnings

Single use – This device was designed for single patient use only. Do not reuse,

reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

7 Precautions

Component packaging – Medtronic has sterilized the contents of the package

according to the process indicated on the package label. Do not use or implant a component if the following circumstances have occurred:

• The storage package or sterile seal has been pierced or altered— because component sterility cannot be guaranteed and infection may occur.

• The component shows signs of damage—because the component may not function properly.

• The use-by date has expired—because component sterility cannot be guaranteed and infection may occur.

Storage temperature – Do not store or transport the package or contents of the package above 57°C (135°F) or below −34°C (−30°F). Temperatures outside this range can damage components.

8 Adverse events

Potential adverse events include, but are not limited to, allergic reaction, bleeding, bruising, infection, injury to the user such as lacerations or pinches, pain, swelling, tissue inflammation, or toxic reaction.

In addition to risks normally associated with surgery, see the appropriate technical manual packaged with system components for a complete list of adverse events.

9 Instructions for use

This manual describes how to use the tunneling tool. Refer to the device implant manual for device description, package contents, device specifications, and instructions for use.

Note: Position the thumbscrew on the handle away from the patient during insertion and removal. This will facilitate handle removal and assist in preventing twisting of the extensions.

9.1 Assembling the tunneling tool

1. Remove the protectors from ends of the shaft.

2. Attach the tunneling tool handle to the shaft: a. Align the drop-shaped end of the shaft with the drop-shaped connection

on the handle (Figure 2). Figure 2. Align the handle and shaft

1 Handle drop-shaped connection 2 Shaft drop-shaped end

b. Push the handle onto the shaft until the mark on the shaft is flush with the

handle (Figure 3).

Figure 3. Attach the handle to the shaft

1 Mark

c. Tighten the thumbscrew located on the handle.

3. Select an obturator tip for tunneling.

4. Slide the obturator through the shaft. The obturator tip will remain exposed at

the end of the shaft. See Figure 4. Figure 4. Obturator slides through the tunneling tool

1 Tunneling tool 2 Obturator

5. Snap the obturator into the handle by folding the obturator down and pressing

it into the groove in the handle (Figure 5).

Figure 5. Snap the obturator into the handle

9.2 Tunneling the catheter

Refer to the catheter technical manual for tunneling procedures.

9.3 Tunneling

1. Identify the tunneling route between the 2 incisions.

Note: Do not bend the shaft at an angle greater than 90° at any one bend. An angle greater than 90° may damage the shaft and prevent the catheter from advancing or damage the catheter.

2. Bend the tunneling tool as necessary.

3. Tunnel subcutaneously until the tip of the obturator is exposed.

Warning: Deep tunneling is not desirable. Deep tunneling may lead to organ perforation or secondary tissue damage.

Caution: Proceed slowly when the tunneling tool approaches the exit incision. If excess force is used, the patient could experience additional trauma when resistance to tunneling suddenly ceases.

Caution: Superficial tunneling is not desirable. Superficial tunneling may lead to skin perforation and infection.

Note: If the tunneling tool does not extend the entire length of the planned route, make an intermediate incision.

4. Remove the obturator.

5. Remove the handle by unscrewing it if necessary.

6. Pass the catheter through the inner lumen of the shaft.

Caution: Use care when inserting the catheter into the shaft. Rough handling may cause damage to the catheter.

7. Pull the shaft from the incision sites.

8. Discard the tunneling tool.

Medtronic, Inc.

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