Publicidad
Idiomas disponibles
Idiomas disponibles
•
Maintain appropriate traction on the lead being extracted during advancement of the TightRail Mini sheath or outer sheath.
•
The TightRail Mini sheath should only be used to minimally enter the vessel. Do not attempt to enter the SVC structure or attempt to navigate the TightRail Mini
sheath into bends beyond the convergence of the innominate and brachiocephalic veins as vessel wall or cardiac lead damage may occur.
•
Excessive advancement force may result in device or vessel wall damage.
5.
PRECAUTIONS
•
Thoroughly review the package insert for conventional lead extraction tools before attempting to use the TightRail Mini sheath.
•
Do not re-sterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination due to inappropriate
reprocessing.
•
Reuse of this single use device could lead to serious patient injury or death and voids manufacturer warranties.
•
Do not use the TightRail Mini sheath if the tamper-evident seal is broken.
•
Do not use the TightRail Mini sheath if any component has been damaged.
•
Prior to the procedure, evaluate the physical dimensions of the lead in relation to the specifications of the dilator sheath to determine compatibility.
•
Due to rapidly evolving lead technology, this device may not be suitable for dilation of tissue around all types of leads. If there are questions or concerns
regarding compatibility of this device with particular leads, contact the lead manufacturer.
•
Do not pull on the lead because it may stretch, distort, or break, making subsequent removal more difficult. Damage to a lead may prevent passage of a lead
locking device through the lumen and/or make dilation of scar tissue more difficult.
•
When the TightRail Mini sheath is in the body, it should be manipulated only under fluoroscopic observation with radiographic equipment that provides high
quality images.
•
As in all extraction procedures using sheaths, use proper sheath technique. Maintain sturdy traction and a stable "rail" position with the lead while keeping
coaxial alignment of the TightRail Mini sheath to minimize the risk of vessel wall damage.
•
When advancing an outer sheath around a bend, keep the point of the sheath's beveled tip oriented toward the inside of the bend.
•
Advancing the TightRail Mini sheath through heavily calcified tissue may require more activations of the dilating mechanism than through fibrous scar
overgrowth.
•
If unable to advance the TightRail Mini sheath despite repeated activations of the dilating mechanism, consider an alternate approach. Be prepared to upsize
to a larger TightRail Mini sheath, move to another lead, try a femoral approach or consider an open procedure.
•
Excessive advancement force may cause temporary binding of the device mechanism.
•
If the lead breaks, evaluate fragment for retrieval.
•
If hypotension develops, rapidly evaluate; treat as appropriate.
•
When removing a chronic pacing lead, be aware that if it is freed spontaneously during the extraction procedure, the lead tip may become trapped in the upper
vasculature. Dilator sheaths, advanced at least to the innominate vein, are often necessary to extract the lead tip through the scar tissue at the site of venous
entry, and to avoid a venotomy.
•
If selectively removing leads with the intent to leave one or more chronic leads implanted intact, the non-targeted leads must be subsequently tested to ensure
that they were not damaged or dislodged during the procedure.
•
If the TightRail Mini sheath is removed from the body for any reason, thoroughly flush the device shaft, inner lumen and tip with saline to remove particles and
prevent blood from sticking before reinserting the TightRail Mini sheath back into the patient.
•
If the TightRail Mini sheath becomes kinked or damaged during use as evidenced by fluoroscopy, it is recommended to discontinue use of the device.
Weigh the relative risks and benefits of device removal versus continued use.
6.
POTENTIAL ADVERSE EVENTS
Potential adverse events related to the procedure of intravascular removal of leads include (listed generally in order of increasing potential effect):
•
Dislodging or damaging non-targeted lead
•
Chest wall hematoma
•
Thrombosis
•
Arrhythmias
•
Bacteremia
•
Hypotension
•
Pneumothorax
•
Migrating fragment from lead
•
Migration of vegetation from lead
•
Pulmonary embolism
•
Laceration or tearing of vascular structures or the myocardium
•
Hemopericardium
•
Cardiac tamponade
•
Hemothorax
•
Stroke
•
Death
7.
INDIVIDUALIZATION OF TREATMENT
Weigh the relative risks and benefits of intravascular lead removal procedures in cases when:
•
Dual coil ICD leads are being removed with proximal coil located in SVC
•
The lead to be removed has a sharp bend or evidence of fracture
•
The lead shows evidence of insulation disintegration raising the concern of pulmonary embolism
•
Vegetations are attached directly to the lead body
P008138-A 09SEP21
(2021-09-09)
TightRail Mini
TM
Rotating Dilator Sheath
Instructions for Use
English / English
4
Publicidad
