Precautions; Potential Adverse Events; Device Preparation; Procedure - Spectranetics Quickcat Gebrauchsanweisung

o
Do not use a bent, kinked or damaged catheter as this may lead to vessel injury and/or an inability to advance or
withdraw the catheter.
o
Do not use for delivery or infusion of diagnostic, embolic, or therapeutic materials into blood vessels.

PRECAUTIONS

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Prior to use, check that all of the connections between components are secure and that the system has been
completely primed or vacuum may be compromised.
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Do not tighten the hemostatic valve excessively onto the catheter shaft, or catheter damage may result.
Use caution when crossing or retracting the QuickCat™ Extraction Catheter across a freshly deployed drug-eluting
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stent.
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Do not re-sterilize, re-process, or re-use the device.
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DO NOT resterilize 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.
o
Do not replace system components with alternate components.

POTENTIAL ADVERSE EVENTS

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Access site bleeding/hematoma
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Anastomotic disruption
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Abrupt closure or total occlusion of treated graft or vessel
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Distal embolization of debris resulting in pulmonary compromise and/or limb ischemia
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Local or systemic infection
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Arterial spasm
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Arteriovenous fistula formation
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Drug reactions, adverse reaction to contrast medium
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Acute myocardial infarction
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Vessel dissection, perforation, rupture or injury
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Emergent surgery
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Death

DEVICE PREPARATION

1. Using sterile technique, open the pouch and transfer the tray into the sterile field.
2. Remove the catheter from the protective coil and inspect for any bends or kinks.
3. Fill the 30 ml vacuum syringe with 5-10 ml of normal saline.
4. Connect the vacuum syringe to the stopcock, the stopcock to the extension tubing, and the extension tubing to the
hub of the QuickCat™ Extraction Catheter. Ensure that all connections are secure.
5. Flush the system with saline to ensure complete priming.
6. Turn the stopcock to the closed position.
7. Remove the 30 mL vacuum syringe and empty any excess saline solution.
8. Re-attach the empty 30 mL vacuum syringe to the system assembly.

PROCEDURE

Using standard technique, cannulate the target vessel with a guidewire and a guiding catheter (I.D. ≥ 0.068‖
1.
[1.73mm]) with an attached hemostatic valve.
Load the QuickCat™ Extraction Catheter onto the guidewire.
2.
WARNING: If any resistance is felt during manipulation, the cause of the resistance must be determined before the
catheter is advanced or withdrawn. Manipulation of the catheter against resistance may result in catheter or vessel
damage. If the catheter becomes kinked during use, carefully remove from the patient and continue procedure with
a new QuickCat™ Extraction Catheter.
Under fluoroscopy, advance the QuickCat™ Extraction Catheter to the target site.
3.
4. Tighten the hemostatic valve sufficiently to prevent backflow, but not so tight as to impede catheter movement.
5. With the stopcock in the closed position, pull back the plunger on the 30 mL syringe to the desired amount of
extraction volume. Twist the plunger clockwise to lock the syringe in the desired vacuum position.
6. Confirm the correct catheter position via fluoroscopy.
Turn the stopcock to the open position to begin the extraction. Slowly advance the QuickCat™ Extraction Catheter
7.
into the target vessel. Blood will enter the syringe until the vacuum is depleted.
8. If blood does not enter syringe within 5 seconds, remove the catheter from the patient. Either flush the catheter
outside of the patient or replace with a new catheter.
WARNING: If flow into the syringe stops or is restricted, do NOT attempt to flush the extraction lumen of the
QuickCat™ Extraction Catheter while the catheter is inside the patient. Serious injury or death may result. Remove
catheter from the patient and flush the extraction lumen before attempting to reuse or use a new QuickCat™
Extraction Catheter.
9. Once the extraction process is complete, turn the stopcock to the closed position and remove the catheter from the
patient. Extracted blood and thrombus may be filtered for visual and/or laboratory analysis using the 40-micron pore
filter basket provided.
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