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Idiomas disponibles
Idiomas disponibles
1.
DEVICE DESCRIPTION
2.
INDICATIONS FOR USE
3.
CONTRAINDICATIONS
4.
WARNINGS
5.
PRECAUTIONS
6.
POTENTIAL ADVERSE EVENTS
7.
INDIVIDUALIZATION OF TREATMENT
8.
HOW SUPPLIED
9.
COMPATIBILITY
10.
DIRECTIONS FOR USE
11.
MANUFACTURER'S LIMITED WARRANTY
12.
NON-STANDARD SYMBOLOGY
1.
DEVICE DESCRIPTION
The TightRail Mini Rotating Dilator Sheath (TightRail Mini sheath) is an intra-operative device designed to facilitate the percutaneous removal of cardiac leads from
the vasculature. TightRail Mini sheath is used in conjunction with conventional lead extraction tools (e.g., locking stylets, outer sheaths). The components of the
Spectranetics TightRail Mini sheath include an inner and outer shaft and a handheld drive mechanism (Figure 1.).
The inner shaft (drive shaft) is able to rotate within the outer shaft to activate the rotary dilating feature at the tip.
The stationary outer shaft is contained within a polymer jacket. The handheld drive mechanism attached to the proximal end of the device is used to rotate the inner
shaft. Rotation of the distal cam of the inner shaft causes dilation of the tissue and fibrous attachments surrounding the lead facilitating the removal of said lead.
An outer sheath is provided that can be used in conjunction with the device to support the device shaft facilitating additional tissue dilation effect and serve as a
conduit for re-implant.
The package includes one 9F or one 11F TightRail Mini sheath and one compatible support outer sheath.
Use with other devices
The TightRail Mini Sheath may be used in conjunction with the Spectranetics Lead Locking Device (LLD®). Follow the "Instructions for Use" for other devices used.
Table 1 provides TightRail Mini Sheath models and sizing specifications.
Table 1. Model Specifications
Tip Inner Diameter
Model
Number
(F)
540-009
9.2
540-011
11.2
2.
INDICATIONS FOR USE
The TightRail Mini Rotating Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
3.
CONTRAINDICATIONS
None known.
4.
WARNINGS
•
Lead removal devices should be used at institutions with cardiothoracic surgical capabilities by physicians knowledgeable in the techniques and devices for
lead removal. Complication prevention and management protocols should be in place and routinely practiced. The recommendations for lead management
of the Heart Rhythm Society
•
When using a locking stylet:
–
Do not abandon a lead in a patient with a locking stylet still in place inside the lead. Severe vessel or endocardial wall damage may result from the stiffened
lead or from fracture or migration of the abandoned stylet wire.
–
Do not apply weighted traction to an inserted locking stylet as myocardial avulsion, hypotension, or venous wall tearing may result.
–
Be aware that leads with a J-shape retention wire occupying their inner lumen (rather than being outside of the coil) may not be compatible with the
locking stylet. Insertion of the locking stylet into such a lead may result in protrusion and possible migration of the J-shape retention wire.
•
Do not insert more than one TightRail Mini sheath or outer sheath into a vein at a time. Do not insert more than one lead into a TightRail Mini device at a time.
Severe vessel damage, including venous wall laceration requiring surgical repair may occur.
P008138-A 09SEP21
(2021-09-09)
Rotating Dilator Sheath
Figure 1. TightRail Mini Sheath Device
(in.)
(mm)
0.119
3.0
0.145
3.7
1
(HRS) and European Heart Rhythm Association
TightRail Mini
TM
Table of Contents
Device Outer Diameter
(F)
(in.)
15.9
0.207
18.0
0.234
2
(EHRA) are highly recommended for best results.
Instructions for Use
Outer Sheath Inner Diameter
(mm)
(F)
5.3
16.6
0.216
5.9
18.7
0.243
English / English
3
3
3
3
4
4
4
5
5
5
6
6
(in.)
(mm)
5.5
6.2
3
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