English/Instructions for Use ........................................1

Vascular Solutions LLC

6464 Sycamore Court North

Minneapolis, MN 55369 USA

(866) 246-6990

(866) 804-9881

Wattson™ temporary pacing guidewire

Instructions For Use

USA CAUTION

Federal law restricts this device to sale by or on the order of a

physician.

DEVICE DESCRIPTION

The Wattson temporary pacing guidewire is a dual-purpose 0.035”

guidewire designed for the delivery of devices and for temporary

pacing of the heart. The distal end of the device has an atraumatic

pigtail shape. The shaft of the device has a lubricious hydrophilic

coating.

Pacing is achieved through a bipolar electrode conguration

integrated in the shaft of the guidewire. The electrodes terminate

in a single positive electrode at the distal tip of the device and

three discrete negative electrodes located proximal to the tip within

the pigtail section. The entire device is visible using standard

uoroscopic methods.

The device is packaged with a proprietary adapter that locks on to

the proximal end of the guidewire and converts it to discrete positive

and negative terminal pins. The terminal pins of the adapter are

compatible with standard external pulse generators.

The Wattson temporary pacing guidewire has been sterilized with

ethylene oxide.

SPECIFICATIONS

Model 2250

Length 280cm

Shaft outer

diameter

0.035” (0.89mm)

Distal

pigtail outer

diameter

30mm

Lubricious

Hydrophilic

Coating

80cm

280 cm

0.035”

(0.89 mm)

30 mm

80 cm

Figure 1: Wattson™ temporary pacing guidewire dimensions

Figure 2: Wattson™ temporary pacing guidewire with adapter

assembly and adaptor pins

INDICATIONS

The Wattson temporary pacing guidewire is intended to introduce

and position catheters and other interventional devices within the

chambers of the heart, including those used within transcatheter

aortic valve replacement (TAVR) procedures and balloon aortic

valvuloplasty (BAV), while transmitting an electrical signal from

an external pulse generator to the heart. The temporary pacing

guidewire is not intended to remain in place following the clinical

procedure.

CONTRAINDICATIONS

The guidewire is contraindicated for use in the coronary arteries and

in the cerebrovasculature.

WARNINGS

Failure to abide by the warnings in this labeling might result in

damage to the device coating, which may necessitate intervention or

result in a serious adverse event.

For patients at high risk of developing new highgrade AV conduction

block during or immediately following the index procedure, the

Wattson temporary pacing guidewire should not constitute the sole

source of ventricular pacing.

The Wattson temporary pacing guidewire is provided sterile for

single use only. Do not reuse or resterilize. Reuse of a single-use

device creates a potential risk of patient or user infections and may

compromise device functionality, which may lead to illness or serious

patient injury.

Never advance or withdraw an intravascular device against

resistance until the cause of the resistance is determined by

uoroscopy. Movement of the guidewire against resistance may

result in separation of the guidewire tip, other damage to the

guidewire, coating material remaining in the vasculature or patient

injury requiring additional intervention.

Do not torque the device, as tip separation or patient injury may

occur.

Inappropriate electrical connections (e.g., into a wall socket) may

pose serious risk of adverse health consequences.

Do not use the guidewire with magnetic resonance imaging (MRI).

PRECAUTIONS

The safety and e󰀨ectiveness of the coated device has not been

established, or is unknown, in vascular regions other than those

specically indicated.

Do not use the Wattson temporary pacing guidewire if the packaging

is damaged. A damaged package could indicate a breach of sterility

or device damage.

Exercise care in handling the guidewire during a procedure to reduce

the possibility of accidental breakage or kinking.

When the guidewire is in the body, it should be manipulated only

under uoroscopy. Do not attempt to move the guidewire without

observing the resultant tip response, as guidewire damage or vessel

injury may occur.

Do not reshape the tip of the guidewire, as tip separation may occur.

Always secure the guidewire prior to advancing or withdrawing an

interventional device over it. Failure to do so may result in loss of

guidewire position and/or vessel injury.

Do not withdraw or manipulate the guidewire in a metal cannula,

needle, or other sharp-edged instrument, as it may impair the

integrity of the polymer coating and compromise the trackability of

the guidewire.

Do not insert other objects into the adapter unless it is the proximal

end of the Wattson temporary pacing guidewire. Inserting other

guidewires or other devices into the adapter may result in adapter

damage.

Care must be taken not to remove the Wattson temporary pacing

guidewire from the adapter or move the guidewire during pacing as

loss of capture or inadequate pacing may result.

ADVERSE EFFECTS

Potential adverse e󰀨ects that may be associated with the temporary

pacing guidewire include, but are not limited to, the following:

• Induction of non-intended arrhythmia

• Dissection

• Embolism

• Hematoma

• Hypotension

• Infection

• Left ventricular perforation

• Stroke

• Tamponade

• Thrombosis

• Sterile inammation or granulomas at the access site

• Additional surgical intervention

CLINICAL PROCEDURE

The Wattson temporary pacing guidewire should be used by

physicians trained on the procedures for which the device is

intended. The techniques and procedures described do not

represent ALL medically acceptable protocols, nor are they intended

as a substitute for the physician’s experience and judgment in

treating any specic patient. All available data, including the patient’s

signs and symptoms and other diagnostic test results, should be

considered before determining a specic treatment plan.

Package contains:

• 1x Guidewire

• 1x Adapter

• 2x Adapter pins

Other items required but not provided:

• External pulse generator

PREPARATIONS FOR USE

1. Prior to use, carefully inspect the guidewire packaging and

components for damage.

2. Utilizing sterile technique, remove the guidewire hoop and

adapter from the packaging and transfer them both to the

sterile eld.

3. Thoroughly ush the guidewire contained within the hoop with

saline to activate the hydrophilic coating.

4. The adapter should be kept from being submerged or doused

with any uid.

DEPLOYMENT PROCEDURE

Deploy the Wattson temporary pacing guidewire according to the

following steps:

1. Following placement of an interventional catheter, utilize the

pigtail straightening tool to load the distal tip of the guidewire

into the catheter hub or hemostasis valve.

2. Advance the guidewire through the catheter and into the

desired chamber of the heart.

3. If desired, catheter exchange over the guidewire can be

performed. Secure the guidewire prior to removing any

catheter over the guidewire or backloading any new catheter

onto the guidewire.

4. If temporary pacing is desired, insert the proximal end of the

guidewire into the proprietary adapter until it securely locks

in place.

NOTE: Carefully wipe to remove any excess uid on the

proximal end of the guidewire prior to insertion into the

adapter.

5. Plug the red, positive terminal pin of the adapter into the

positive port of the standard external pulse generator. Plug the

black, negative terminal pin of the adapter into the negative

port of the standard external pulse generator.

NOTE: Adaptor pins are available if the external pulse

generator requires unshrouded pins.

6. Test the pacing characteristics of the device while the distal tip

of the guidewire is positioned in the desired cardiac location

for optimal pacing.

7. Pace the heart per individual institutional protocol and

manufacturer’s instructions for the external pulse generator

used.

8. Once pacing is complete, the adapter can be removed from

the guidewire by pressing the black, quick release button and

withdrawing the proximal end of the wire.

9. Once the intervention is complete, advance the interventional

catheter back through the chambers of the heart to remove

the guidewire from the vasculature.

10. Dispose of the product following standard hospital

procedures.

STORAGE & HANDLING

No special storage or handling conditions.

LIMITED WARRANTY

Vascular Solutions LLC warrants that the Wattson temporary pacing

guidewire is free from defects in workmanship and materials prior

to the stated expiration date. Liability under this warranty is limited

to refund or replacement of any product, which has been found by

Vascular Solutions LLC to be defective in workmanship or materials.

Vascular Solutions LLC shall not be liable for any incidental, special

or consequential damages arising from the use of the Wattson

temporary pacing guidewire. Damage to the product through misuse,

alteration, improper storage or improper handling shall void this

limited warranty.

No employee, agent or distributor of Vascular Solutions LLC has any

authority to alter or amend this limited warranty in any respect. Any

purported alteration or amendment shall not be enforceable against

Vascular Solutions LLC.

THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER

WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY

WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE OR ANY OTHER OBLIGATION OF

VASCULAR SOLUTIONS LLC.

PATENTS AND TRADEMARKS

May be covered by one or more U.S. or international patents.

See: www.teleex.com/patents-intv

Teleex, the Teleex logo, and Wattson are trademarks or registered

trademarks of Teleex Incorporated or its a󰀩liates in the U.S. and/

or other countries.

See the International Symbols Glossary on page 3.

See the Content Glossary on page 4.

Symbol Title of Symbol Explanatory Text

Phone Number

Phone Number Indicates the medical device manufacturer phone number.

Fax Number

Fax Number Indicates the medical device manufacturer fax number.

Rx ONLY Prescription Use Only Indicates a medical device that is prescription use only.

Use-by date Indicates the date after which the medical device is not to be used.

Catalog Number Indicates the manufacturer’s catalogue number so that the medical

device can be identied.

Sterilized using

ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide.

Do not re-use

Do not re-use Indicates a medical device that is intended for one use, or for use on a

single patient during a single procedure.

Do not use if

package is

damaged

Do not use if package

is damaged

Indicates a medical device that should not be used if the package has

been damaged or opened.

Caution, consult

accompanying

documents

Caution

Indicates the need for the user to consult the instructions for use for

information such as warnings and precautions that cannot, for a variety

of reasons, be presented on the medical device itself.

Non-pyrogenic

Non-pyrogenic Indicates a medical device that is non-pyrogenic.

Manufactured by

Manufacturer Indicates the medical device manufacturer.

Batch code Indicates the manufacturer’s batch code so that the batch or lot can be

identied.

Type CF applied part Electrically connected to the heart of the patient.

International Symbols Glossary

Content Glossary

280 cm

0.035”

(0.89 mm)

30 mm

80 cm

Content Glossary Guidewire Adapter Adaptor Pins