Idiomas disponibles
Idiomas disponibles
8.
HOW SUPPLIED
8.1
Sterilization
•
For single use only. Not for re-sterilization or reprocessing.
•
Ethylene Oxide Sterilized
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Non-pyrogenic
•
Sterility guaranteed if package is unopened and undamaged.
•
Store device in a dry cool place (below 60° C / 140° F) until use.
8.2
Inspection Prior to Use
•
Before use, visually inspect the sterile package to ensure that seals have not been broken. All equipment to be used for the procedure, including the TightRail
Mini sheath, should be examined carefully for defects. Examine the TightRail Mini sheath for kinks or other damage. Do not use the product if it is damaged
or if the Use-by Date has been exceeded.
9.
COMPATIBILITY
Information for determining TightRail Mini sheath dimensional compatibility is shown in Table 1.
10. DIRECTIONS FOR USE
10.1
Procedure Set Up
TightRail Mini Sheath Preparations:
Using sterile technique, open the sterile package. Remove the lid from the tray and gently lift the device from the tray while supporting the handle and shaft.
Patient Preparations:
1. Obtain a thorough patient history, including patient blood type. Appropriate blood products should be readily available.
2. Determine the manufacturer, model number and implant date of the lead to be removed. Perform radiographic/echocardiographic evaluation of lead
condition, type and position.
3. Use a procedure room that has high quality fluoroscopy, pacing equipment, defibrillator, and thoracotomy and pericardiocentesis trays.
4. Prep and drape the patient's chest for possible thoracotomy; prep and drape the patient's groin for a possible femoral approach extraction procedure.
5. Arrange for immediate surgical back-up.
6. Establish back-up pacing as needed.
7. Have available additional TightRail Mini sheaths, other sheaths, locking stylets, stylets to unscrew active fixation leads, snares (femoral workstation) and any
other accessory equipment deemed necessary.
10.2
Clinical Technique
1. Patients are prepared for multiple lead extraction approaches, including an emergency cardiac surgical intervention. Preparations may include: general
endotracheal anesthesia or conscious sedation, shave and preparation of both the chest and groin areas, ECG monitoring, insertion of an arterial line and a
Foley catheter, presence of instruments for pacing and defibrillation, an electrosurgical unit, and a sternal saw for emergencies.
2. A temporary pacing lead is inserted in all patients needing a pacemaker. An exception is made for patients with an implanted permanent pacemaker whose
leads are not to be extracted.
3. Fluoroscopy will be used to monitor all transvenous maneuvers.
4. Expose the proximal end of the lead and sever any suture holding the anchoring sleeve suture. Debride overgrowth from the lead as required to expose the
venous entry site. Sever the lead terminal pin and remove the anchoring sleeve.
5. For active fixation leads, unscrew the lead helix.
6. Sever the lead terminal pin connector and remove the anchoring sleeve.
7. Insert and lock a Lead Locking Device into the lead as distal as possible and deploy the locking mechanism. Secure appropriate lengths of suture material to
the proximal end of the lead insulation and high voltage cables to provide additional traction.
8. Hydrate the inner lumen of the TightRail Mini sheath and wet the outer jacket.
9. If using an outer sheath, flush the inner lumen and place over the TightRail Mini sheath.
10. Support the handle and shaft of the TightRail Mini device while loading the device onto the locking stylet and target lead.
11. Extraction technique:
a. Apply sturdy traction on the lead and/or its locking stylet to maintain a stable "rail" position with the lead while keeping coaxial alignment of the TightRail
Mini sheath. This is critical to safe passage of the TightRail Mini sheath over the lead. If traction is inadequate, the lead may buckle, precluding the TightRail
Mini sheath from advancing along the appropriate path.
b. With the lead in tension, advance the TightRail Mini sheath over the lead until an obstruction is met. When using an outer sheath, use an "inchworm"
technique to alternately advance the outer sheath and the TightRail Mini sheath over the lead.
c. Use the following guidelines to determine if a tissue obstruction is met:
•
The TightRail Mini sheath will not advance into the vein.
•
The TightRail Mini sheath bows when longitudinal pressure is applied.
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Fluoroscopy shows that the sheath tip does not advance relative to the lead body.
•
Fluoroscopy shows that the TightRail Mini sheath tip is not caught on a lead electrode, a lead bend, or another lead.
d. When an obstruction is met and the TightRail Mini sheath cannot be advanced:
•
Use AP and oblique fluoroscopic views to ensure that the tip of the TightRail Mini sheath is aligned and coaxial with the longitudinal axis of the lead.
•
If the optional outer sheath is being used,retract the outer sheath so that its distal end does not overlap the tip of the TightRail Mini sheath. Press the
TightRail Mini sheath gently into the obstructing tissue.
•
Use gentle pressure on the TightRail Mini sheath to advance the device while squeezing the trigger to activate the inner shaft's dilating mechanism.
Apply traction to the locking stylet while advancing and dilating tissue.
•
With each full squeeze of the trigger, the dilating mechanism will extend, rotate, and retract. The dilating mechanism retracts into the sheath tip when
the trigger is fully released.
•
If the trigger is partially squeezed the rotational direction of the dilation mechanism may not change directions.
•
Return the trigger to a fully forward position between each subsequent squeeze.
P008138-A 09SEP21
(2021-09-09)
TightRail Mini
TM
Rotating Dilator Sheath
Instructions for Use
English / English
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