Tabla De Contenido; Description; Lld And Clearing Stylet; Lead Cutter - Spectranetics LLD Instrucciones De Uso

Table of Contents
1. Description ...................................................................................................................... 3
1.1 LLD and Clearing Stylet................................................................................... 3
1.2 Lead Cutter...................................................................................................... 3
1.3 Accessory Kit .................................................................................................. 3
1.4 LLD Size Selection .......................................................................................... 3
2. Indications for Use........................................................................................................... 3
3. Contraindications ............................................................................................................ 3
4. Warnings ......................................................................................................................... 4
5. Precautions ..................................................................................................................... 4
6. Adverse Events................................................................................................................ 4
7. Individualization of Treatment .......................................................................................... 4
Operator's Manual ........................................................................................................... 4
8.
8.1 Sterilization...................................................................................................... 4
8.2 Device/Packing Care ....................................................................................... 4
8.3 Inspection Prior to Use .................................................................................... 4
8.4 Procedure Set Up ............................................................................................ 4
9. Instructions for Use of the LLD ........................................................................................ 4
9.1 Clinical Technique ........................................................................................... 5
Manufacturer's Limited Warranty ..................................................................................... 5
10.
Federal (USA) law restricts this device to sale by or on the order of a physician with
appropriate training.
1.

Description

1.1

LLD and Clearing Stylet

The Spectranetics Lead Locking Device or LLD is comprised of two wire loop handles
and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is
attached at the distal end within a radiopaque marker for visibility under fluoroscopy.
The proximal end of the mesh is attached to a proximal connector which is used to
deploy and lock the device into the pacing or defibrillator lead. The proximal connector
is seated on a crimped section of the core mandrel until it is deployed. The connector
slides distally from the crimped section and deploys the mesh inside the lead.
Figure 1: Non-Deployed LLD, "Insertion" Configuration
Figure 2: Deployed LLD, "Locked" Configuration
The LLD is packaged with a clearing stylet. The clearing stylet consists of a stainless
steel mandrel attached to a proximal handle. Table 1 identifies LLD device ranges and
Clearing Stylet sizes.
P 0 0 4 7 7 7 - 0 2
1 3 D e c 1 1
( 2 0 1 1 - 1 2 - 1 3 )
Lead Locking Device (LLD

Accessory Kit

Lead Cutter

INSTRUCTIONS FOR USE
Number
518 - 018
518 - 021
518 - 019
518 - 022
518 - 020
518 - 023
518 - 039
518 - 062
518 - 067
1.2 Lead Cutter
The Spectranetics Lead Cutter is used to gain access to the inner lumen of a pacing/
defibrillator lead by cutting through the insulation and coils cleanly. The lead cutter is
constructed with stainless steel.
1.3 Accessory Kit
The Spectranetics Accessory Kit contains a Coil Expander and two Pin Gauges.
Coil Expander: Used to restore the proximal end of lead coils to a circular profile. The
Coil Expander contains a stainless steel tapered pin inserted into a polycarbonate
handle. The Coil Expander opens the proximal end of the lead coil. This process
promotes an accurate measurement by the Pin Gauges.
Pin Gauges: The Pin Gauges are used to determine which Lead Locking Device (LLD)
is appropriate for the pacing/defibrillator lead to be extracted. The Pin Gauges are
made with stainless steel pins inserted into a polycarbonate handle. Each Pin Gauge
contains two pins. One Pin Gauge has the #1 and E/EZ pins, the second Pin Gauge
has the #2 and #3 pins.
1.4

LLD Size Selection

The appropriate LLD is selected by using the Spectranetics Pin Gauges as described
on Table 2 below.
*
For leads with internal diameter greater than 0.023‖ / 0.58mm, select LLD #2
The LLD may be used in conjunction with the Spectranetics Laser Sheath Kit or other
necessary extraction devices.
Closely follow the Instructions for Use for any device used during the extraction
procedure.
NOTE: The LLD is a single use disposable device and is intended to be used in one
lead.
NOTE: Any device used over the lead to be extracted must have an ID greater than the
target lead maximum diameter.
2.

Indications for Use

The Spectranetics Lead Locking Devices, LLD,
suitable for transvenous removal of chronically implanted pacing or defibrillator leads
having an inner lumen and using a superior venous approach.
3.

Contraindications

Use of the LLD is contraindicated:
®
)
Table 1: Device Range
Lead Internal
Model Device Diameter
Number Range
in / mm
0.013 - 0.016 /
LLD #1
0.33 - 0.41
0.017 - 0.026 /
LLD #2
0.43 - 0.66
0.027 - 0.032 /
LLD #3
0.69 - 0.81
0.015 - 0.023/
LLD E
0.38 - 0.58
0.015 - 0.023 /
LLD EZ
0.38 - 0.58
Table 2: Selection Chart
Pin Number
Pin #1 fits but not E/EZ
Pin E/EZ fits but not #2
Pin #2 fits but not #3
Pin #3 fits
When emergency thoracotomy with cardiopulmonary bypass cannot be performed
immediately in the event of a life threatening complication;
When fluoroscopy is not available;
In patients in whom superior venous approach cannot be used;
Clearing Stylet
Number
Diameter (in/mm)
1
(0.012 / 0.30)
2
(0.015 / 0.38)
2
(0.015 / 0.38)
1
(0.012 / 0.30)
1
(0.012 / 0.30)
Select LLD
#1
E or EZ
*
#2, E, or EZ
#3
are intended for use in patients
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