Inhaltsverzeichnis - Spectranetics Quickcat Gebrauchsanweisung

DEVICE DESCRIPTION ............................................................................................................................................... 3
DEVICE COMPONENTS .............................................................................................................................................. 3
INDICATIONS AND INTENDED USE ........................................................................................................................... 3
CONTRAINDICATIONS ............................................................................................................................................... 3
WARNINGS ................................................................................................................................................................. 3
PRECAUTIONS ........................................................................................................................................................... 4
POTENTIAL ADVERSE EVENTS ................................................................................................................................. 4
DEVICE PREPARATION.............................................................................................................................................. 4
PROCEDURE .............................................................................................................................................................. 4
POST-PROCEDURE CARE ......................................................................................................................................... 5
HOW SUPPLIED .......................................................................................................................................................... 5
STORAGE CONDITIONS ............................................................................................................................................. 5
WARRANTY INFORMATION ....................................................................................................................................... 5
Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these
instructions. Failure to observe warnings and precautions may result in complications. Any recommendations
within these instructions are designed to serve only as a general guideline. They are not intended to supersede
institutional protocols or professional clinical judgment concerning patient care.
CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The QuickCat™ Extraction Catheter is a single use, disposable dual-lumen catheter designed for removing soft emboli
and thrombi from vessels of the arterial system. The distal tip of the catheter is pliable, tapered, and smooth, providing
atraumatic passage into the arterial system. The device is supplied sterile and is intended for one time use only.
DEVICE COMPONENTS
o
Catheter:
o
Vacuum Assembly:
INDICATIONS AND INTENDED USE
The QuickCat™ Extraction Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels in the arterial
system.
Product is intended for single use by physicians trained and experienced in diagnostic and interventional techniques.
Standard techniques for placement of vascular access sheath, angiographic catheters and guidewires may be employed.
CONTRAINDICATIONS
o
Use in vessels with a diameter < 1.5 mm
o
The venous system
o
The removal of fibrous, adherent or calcified material (e.g. chronic clot, atherosclerotic plaque)
WARNINGS
o
Do not use without a guidewire, as vessel injury may result.
o
Do not attempt to advance or retract the catheter against resistance until the cause of resistance has been
determined by fluoroscopy or other means. Manipulation of the catheter against resistance may result in kinking of
the catheter and/or vessel damage.
o
If excessive slack or a loop in the guidewire is observed between the guide catheter and the monorail segment of the
QuickCat™ Extraction Catheter during the procedure, the guidewire may become kinked within the vessel during
catheter advancement or retraction. Remove the slack or loop in the guidewire before advancing or retracting the
QuickCat™ Catheter to avoid catheter and/or vessel damage.
If flow into the syringe stops or is restricted, do NOT attempt to flush the extraction lumen of the QuickCat™
o
Extraction Catheter while the catheter is inside the patient. Serious injury or death may result.
P003602-09
02Dec11
(2011-12-02)
QUICKCAT™ EXTRACTION CATHETER
INSTRUCTIONS FOR USE
The QuickCat™ Extraction Catheter is compatible with 6F guide catheters [I.D. ≥ 0.068‖
(1.73 mm)] and 0.014‖ (0.36 mm) guidewires. The catheter has a working length of 145 cm
and its distal portion is covered with a hydrophilic coating. There is a radiopaque marker
approximately 1 mm from the tip.
The vacuum assembly consists of a 7.0‖ (177.8 mm) extension tubing, one-way stopcock
and a 30 mL vacuum syringe with adjustable locking plunger. A 40-micron pore filter
basket is provided to assist in filtering of blood and thrombotic material for visual or
laboratory analysis.
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