Penumbra INDIGO Gebrauchanweisung

INSTRUCTIONS
FOR USE
I P
ntended urPose
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using
mechanical aspiration.
d d
evIce escrIPtIon
The INDIGO Aspiration System is comprised of several devices:
®
• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator™
The INDIGO Aspiration Catheter targets aspiration from the Penumbra Aspiration Pump directly
to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO
Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter
is introduced through a guide catheter or vascular sheath into the peripheral vasculature and
guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter
is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As
needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist
with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO
Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the
thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy.
For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the
Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the
INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a
steam shaping mandrel and rotating hemostasis valve, and introducer. The INDIGO Separator
may be provided with an introducer and torque device.
INDIGO System Aspiration Catheters have a hydrophilic coating on the distal segment of the
catheter shaft (see Table 1)
Table 1 – Hydrophilic Coating Length
INDIGO Aspiration
Catheter
CAT3
CAT5
CAT6
CAT7/ CAT7D
CAT8/ CATD
CAT12
I u
ndIcatIon for se
INDIGO Aspiration Catheters and Separators
As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are
indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial
and venous systems, and for the treatment of pulmonary embolism.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to
connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration
Systems.
I P P
ntended atIent oPulatIon
The intended patient population for the INDIGO Aspiration System is patients with soft emboli or
thrombi in peripheral arteries and veins, and/or for patients with pulmonary embolism.
c
ontraIndIcatIons
Not for use in the coronaries or the neurovasculature.
W
arnIngs
• The INDIGO Aspiration System should only be used by physicians who have received
appropriate training in interventional techniques.
• Do not advance, retract, or use any component of the INDIGO System against resistance
without careful assessment of the cause using fluoroscopy. If the cause cannot be
determined, withdraw the device or system as a unit. Unrestrained torquing or forced
insertion of the catheter or separator against resistance may result in damage to the device
or vessel.
Length (cm)
75
30
11
14
7
22
R
• Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration
Pump.
• Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of
aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery
branches can result in vessel perforation.
P
recautIons
• The device is intended for single use only. Do not resterilize or reuse. Resterilization or reuse
of the device may compromise the structural integrity of the device and/or lead to device
failure which in turn, may result in patient injury, illness or death.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all
damaged devices and packaging to the manufacturer / distributor.
• Use prior to the "Use By" date.
• Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization.
• Maintain a constant infusion of appropriate flush solution.
• When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the
minimum time needed to remove thrombus. Excessive aspiration or failure to close the
INDIGO Aspiration Tubing when aspiration is complete is not recommended.
• Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss
from the clot aspiration procedure.
• The INDIGO Separator is not intended for use as a guidewire. If repositioning of the INDIGO
Aspiration Catheter is necessary during the revascularization procedure, such repositioning
should be performed over an appropriate guidewire using standard catheter and guidewire
techniques.
• Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration
Catheter because it may damage the device.
• The INDIGO Separator (SEP3) contains CMR substances (CAS Number: 7440-48-4 and
1344-37-2). The INDIGO Separators (SEP5, and SEP6) contain a CMR substance (CAS
Number: 7440-48-4).
IndIgo P a
otentIal dverse
Possible complications include, but are not limited to, the following:
• acute vessel occlusion
• air embolism
• allergic reaction and anaphylaxis from
contrast media or device material
• anemia
• arrhythmia
• arteriovenous fistula
• cardiac injury, cardiac perforation, cardiac
tamponade
• cardio-respiratory arrest
• compartment syndrome
• death
• emboli
• emergent surgery
• foreign body embolization
• hematoma or hemorrhage at access site
• hemoptysis
• hemorrhage
*If a serious incident related to the device occurs, contact your Penumbra, Inc. representative
and the competent authority in your respective country/region.
P
rocedure
1. Refer to Warnings, Precautions, and Potential Adverse Events prior to use.
2. Refer to Table 2 for device compatibility information.
3. As each device of the INDIGO Aspiration System is used, remove the device from the
packaging and inspect for damage or for kinks.
4. Prepare INDIGO Aspiration System devices for use by flushing the packaging and device
with heparinized saline (includes INDIGO Aspiration Catheter and INDIGO Separator only).
5. Prepare a guide catheter or vascular sheath according to the manufacturer's Instructions for
Use.
6. Using conventional catheterization techniques under fluoroscopic guidance, place the
guide catheter or vascular sheath into the appropriate artery or vein that is proximal to the
thrombus occlusion site over an appropriate guidewire.
1 (64)
Aspiration System
e
vents
• hypotension/hypertension
• infarction leading to organ damage
• infection
• ischemia
• myocardial infarction
• neurological deficits including stroke
• pneumothorax
• pseudoaneurysm
• renal impairment or acute renal failure from
contrast media
• residual thrombus due to inability to
completely remove thrombus or control
blood flow
• respiratory failure
• valvular damage
• vessel spasm, thrombosis, dissection
(intimal disruption), or perforation
INDIGO
®