Directional Atherectomy System
Sistema de aterectomía direccional
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
PRECAUCIÓN: Las leyes federales de los Estados Unidos únicamente permiten la venta de este producto si es
efectuada por un médico o bajo prescripción facultativa.
Instructions For Use
Device Description
The HawkOne™ directional atherectomy system (HawkOne™ catheter and cutter driver) is designed for the
treatment of de novo and restenotic atherosclerotic calcied and non-calcied lesions located in native
peripheral arteries. When treating complex, hard, calcied lesions, pairing the HawkOne catheter with the
SpiderFX™ embolic protection device mitigates risk of distal embolization that can be generated when heavily
calcied plaque breaks down. (For information about the SpiderFX embolic protection device, reference the
Instructions for Use provided with the device.)
The HawkOne catheter consists of a exible shaft designed to track with a 0.36mm (0.014in) guidewire. At the
distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates within
a tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning
lever (thumb switch) designed to t into the cutter driver. The cutter driver (catalog number H1-14550) is
a battery-driven, internally powered device, designed to power the HawkOne™ directional atherectomy
catheter.
The HawkOne directional atherectomy system has two switches:1) the main power switch on the cutter driver
and2) the cutter positioning lever (thumb switch) on the HawkOne catheter. The main power switch on the
cutter driver supplies power to the device when turned on. When the thumb switch is pulled proximally to
the On position, the HawkOne catheter activates the drive shaft and the cutter. With the cutter engaged, the
HawkOne catheter is slowly advanced across the lesion, shaving occlusive material from the artery. The excised
tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the
HawkOne catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the
HawkOne catheter thumb switch is fully advanced distally to the O position, excised tissue is packed into the
tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.
Device Compatibility
The HawkOne™ cutter driver (catalog number H1-14550) is not backward compatible with previously released
TurboHawk™ and SilverHawk™ catheters. It is designed to work with the catheter models listed in Table1.
The HawkOne catheter models listed in Table1 are not compatible with previously released cutter drivers
(catalog number FG-02550).
Table1. HawkOne™ system specications and cutter driver compatibility
Specication Catalog Number
Product Catalog Number H1-LS H1-LX H1-M H1-S
Model: LS LX M S
Compatible cutter driver: H1-14550 H1-14550 H1-14550 H1-14550
Eective length: 107cm 104cm 129cm 145cm
Tip length: 6.6cm 9.6cm 5.9cm 5.9cm
Maximum catheter prole: 2.6mm 2.6mm 2.2mm 2.2mm
Recommended sheath size:
Maximum guidewire diameter:
Vessel range: 3.5–7.0mm 3.5–7.0mm 3.0–7.0mm 2.0–4.0mm
Nominal voltage: 9V 9V 9 V 9V
Note: The cutter driver is protected against electrical shock (debrillation-proof type, CF). Keep the cutter
driver dry (IPX0).
Indications For Use
The HawkOne™ directional atherectomy system is intended for use in atherectomy of the peripheral
vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection
device in the treatment of severely calcied lesions. The HawkOne catheter is NOT intended for use in the
coronary, carotid, iliac, or renal vasculature.
Contraindications
• Do not use in the coronary arteries, carotid artery, or in the iliac, or renal vasculature
• Do not use for in-stent restenosis at the peripheral vascular site
Warnings
• Pair the SpiderFX™ embolic protection device with the HawkOne catheter when used in complex,
hard, calcified lesions. Pairing the SpiderFX device with the HawkOne catheter mitigates risk of distal
embolization that can be generated by the breakdown of heavily calcified plaque. Refer to the sizing
guide in the SpiderFX Instructions for Use provided with the SpiderFX device.
• The HawkOne catheter should only be used by physicians trained in percutaneous peripheral
interventional procedures.
• Limit use of this device to facilities where surgical support is readily available in the event of a serious
complication.
7F
(2.5mm)
0.36mm
(0.014in)
Catheter:
7F
(2.5mm)
0.36mm
(0.014in)
Cutter positioning lever (thumb switch)
6F
(2.2mm)
0.36mm
(0.014in)
6F
(2.2mm)
0.36mm
(0.014in)
Figure1. Illustration and Nomenclature
• The HawkOne catheter may only be used with the H1-14550 cutter driver.
• Use of the cutter driver is limited to a normal clinical environment (temperature 10–28°C; pressure 700–
1060hPa; humidity 30–75%).
• Do not use the device after the labeled “Use By” expiration date.
• This device is not to be used in the presence of combustible or flammable gases, anesthetics, cleaners,
disinfectants, or in an oxygen-rich environment.
• This device is supplied sterile for single use only. Do not reprocess or resterilize. Reprocessing and
resterilizing could increase the risk of patient infection and risk of compromised device performance. In
case of damage to the packaging or the device, discard the unit.
• Always use direct fluoroscopic observation when manipulating the HawkOne catheter in the peripheral
vessels. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
• Avoid excessive movement of the HawkOne catheter within the vessel at all times. Excess movement
could result in embolization or vessel damage. In addition, excessive catheter manipulation while the
cutter window is open could result in the embolization of previously excised tissue fragments.
• The cutter section of the HawkOne catheter is a rigid component. Vessel trauma or device failure can
result if excessive force or torque is used to advance the catheter.
• Do not use the HawkOne catheter in bends in excess of 90°. Using in bends in excess of 90° can result in
device failure.
• Never advance the distal tip of the HawkOne catheter near the floppy end of the guidewire. If the
HawkOne catheter is advanced to this position, it can cause the guidewire to buckle into a loop when
retracting the catheter. If buckling occurs, remove the catheter and guidewire together to prevent
potential damage to vessel walls. If resistance is still felt, remove the sheath together with the guidewire
and catheter.
• Operating the device with the blade partially opened or closed could result in vessel trauma or possible
embolization of previously excised tissue.
• When using the SpiderFX™ device in combination with the HawkOne catheter, never advance the distal
tip of the HawkOne catheter near the proximal radiopaque marker band of the SpiderFX device. Contact
with the marker band can result in distal embolization of the captured debris, as well as vessel trauma or
device failure.
• Exceeding the recommended maximum length of cut or storage capacity of the catheter tip before
removing and emptying the device increases the risk of embolized excised tissue fragments.
• If the HawkOne catheter does not advance easily, close the cutter by advancing the thumb switch. Do not
use excessive force to advance the thumb switch. Assess whether device repositioning or predilation is
required.
• Avoid using this equipment if it is adjacent to, or stacked with, other equipment. Such use could cause
this equipment to operate improperly. If this equipment must be set up adjacent to, or stacked with, other
equipment verify that all the equipment is operating properly.
• Use of accessories, transducers, and cables (other than those specified or provided by Medtronic) could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment,
and could result in improper operation.
• Use portable RF communication equipment (including cables specified by Medtronic or peripherals
given as antenna cables and external antennas) no closer than 30cm (12in) of any part of the HawkOne
directional atherectomy system. If the communication equipment is too close to the HawkOne™ system,
the system’s performance could be compromised.
Precautions
• Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
• The HawkOne catheter (model numbers LS, LX, M, and S) and the cutter driver (model number H1-14550)
are not backward compatible with previously released models. See Table1 for compatibility information.
• Do not attempt to disconnect the catheter from the cutter driver after they are connected and
locked. Disconnecting the catheter from the cutter driver after locking damages the system, making it
non-functional.
• Do not sharply bend or kink the HawkOne catheter shaft during handling. Sharply bending or kinking the
catheter shaft could damage the device and impair its function.
• Do not attempt to remove the distal flush tool from the catheter. Removing the distal flush tool damages
the catheter, making it non-functional.
• Refer to Table1 for recommended sheath size requirements. Using smaller than recommended sheaths
can compromise device performance.
• When using the SpiderFX device in combination with the HawkOne catheter, the SpiderFX™ filter must
be deployed in such a way that the proximal radiopaque marker is no less than 7cm (for M and S use),
8cm (for LS use), or 11cm (for LX use) distal to the lesion. Failure to appropriately place the filter can
compromise device performance.
• The guidewire must go through both lumens; otherwise, the distal flush window on the tip may be open.
Operating the device with the distal flush window open could result in the embolization of excised tissue.
• Do not use excessive force, pinch, or bend the tip of the catheter when inserting the catheter through
the hemostasis valve of the sheath. Using excessive force, pinching, or bending the tip may damage the
device and impair its function.
• If using a Tuohy-Borst sheath, do not over-tighten the Tuohy-Borst hemostasis valve. Overtightening the
Tuohy-Borst hemostasis valve may inhibit smooth advancement and rotation of the HawkOne™ catheter
or damage the shaft.
• Do not torque the catheter shaft more than 360° in one direction. Torquing the catheter shaft more than
360° in one direction could result in tip fracture or other device failure. If the HawkOne catheter is not
rotating easily, reposition the catheter or predilate the lesion.
• The cutter driver is not designed for continuous operation. Do not run the cutter driver for more than
Shaft
Cutter window
Closed
Cutter window
Open
Flush port
Torque knob
Tip deected
Strain relief
Distal ush tool
Distal ush window
Distal tip
Cutter Driver:
Main power switch
Insert catheter into cutter driver handle
2EnglishInstructions for Use
15minutes in any 30minute period.
• Avoid using excessive force when removing tissue with tweezers to avoid damaging the device.
• Cutting extended lengths in severely calcified lesions can result in cutter wear. Encountering increased
resistance during a cutting pass could indicate that the device needs to be replaced.
• The cutter driver is a single use device. Do not open the cutter driver casing, modify the cutter driver
components, or change the cutter driver battery. Opening or modifying the cutter driver could result in
damage to the device or injury to the patient or physician.
Potential Adverse Events
Potential adverse events associated with the use of this device and other interventional catheters include, but
are not limited to, the following:
• Amputation • Embolism or arterial thrombosis
• Aneurysm • Emergency or non-emergency arterial bypass surgery
• Arterial dissection • Entry site complications
• Arterial perforation • Hypotension
• Arterial rupture • Infection
• Arterial spasm • Ischemia
• Arteriovenous fistula • Restenosis of the treated segment
• Bleeding complications • Total occlusion of the peripheral artery
• Death • Vascular complications that could require surgical repair
Summary Of DEFINITIVE Ca++ Study
The following DEFINITIVE Ca++ study data are for the SilverHawk and TurboHawk plaque excision systems.
Although the HawkOne directional atherectomy system was not part of the study, it is similar in design to the
clinically evaluated plaque excision systems. Thus, the Denitive Ca++ study data provides clinical insight into
how the HawkOne device is expected to perform.
DEFINITIVE Ca++ was a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and
eectiveness of the SilverHawk™/TurboHawk™ plaque excision systems and the SpiderFX™ embolic protection
device for the treatment of moderate to severely calcied peripheral arterial disease in the supercial femoral
or popliteal arteries. An independent angiographic core laboratory and a Clinical Events Committee (CEC) were
employed to ensure unbiased review and classication of events and endpoints. 133subjects from 17centers
were enrolled. A summary of safety and eectiveness data is provided in Table2.
Table2. DEFINITIVE Ca++ Summary of Safety and Eectiveness
Angiographic core
laboratory reported
results
Parameters
Site reported
results
Baseline Demographics
Age (mean ± SD) 69.7 ± 9.8
Male 71.4% (95/133)
Severe calcication 81.0% (136/168)
Reference vessel diameter (mm) [mean ± SD (N)] 4.9 ± 0.9 (168)
Target lesion length (mm) [mean ± SD (N)] 39.0 ± 27.0 (168)
Pre-procedure diameter stenosis (%) [mean ± SD (N)] 76.5 ± 15.4 (168)
Primary Eectiveness Endpoint
Successful revascularization ( ≤50% residual diameter
stenosis following plaque excision)
97.0% (162/167) 92.0% (150/163)
Primary Safety Endpoint (Per angiographic core laboratory review and CEC adjudication)
30-day MAE-free rate 93.1% (122/131)
Death 0.0% (0/131)
Acute myocardial infarction 0.8% (1/131)
Dissection, target vessel (gradeC) 0.0% (0/131)
Dissection, target vessel (gradeD or greater) 0.8% (1/131)
Clinical perforation, target vessel 2.3% (3/131)
Pseudoaneurysm, target vessel 0.0% (0/131)
Thrombosis, target vessel 0.8% (1/131)
Distal embolism 2.3% (3/131)
Amputation, above metatarsal line 0.0% (0/131)
Clinically-driven target vessel revascularization 0.0% (0/131)
The proportion of subjects event-free (per angiographic core laboratory review and CEC adjudication) after
30days was compared to a performance goal of 85.5% based on the TALON registry
rate was 93.1% (122/131). The 95% lower condence limit was 88.3% (as calculated by the Exact method),
greater than the performance goal of 85.5%. Therefore, the primary safety endpoint was met as assessed by
the angiographic core laboratory2.
The primary eectiveness endpoint was successful revascularization of the target vessel (dened as less than
or equal to 50% residual diameter stenosis following plaque excision), as adjudicated by the angiographic core
laboratory. The proportion of lesions meeting this criterion was compared to a performance goal of 90.0%
based on the TALON registry. Results of residual diameter percentage stenosis results from the TALON registry
were based on site-reported data. Per angiographic core laboratory assessment, the primary eectiveness
criterion (≤50% residual diameter stenosis) was achieved in 92.0% (150/163) of lesions. The lower bound of
the condence interval is 87.6%. Therefore, the eectiveness endpoint was not met.
The protocol mandated the use of an independent angiographic core laboratory to apply consistency and
an unbiased assessment to residual diameter stenosis; however, the primary eectiveness performance goal
was based on site-reported residual diameter stenosis from the TALON registry. The dierences between siteassessed residual diameter stenosis data and angiographic core laboratory-assessed residual diameter stenosis
data that were seen in this study are consistent in direction and magnitude with other studies.
Per angiographic core laboratory assessment, the primary endpoint success criterion was achieved in 97.0%
(162/167) of lesions. The lower bound of the condence interval is 93.8%, which is above the 90% performance
goal that was derived from the TALON site-reported data.
How Supplied
The HawkOne catheter and cutter driver are packaged and sterilized individually, and are shipped in two shelf
cartons. Both are intended for single patient use only.
Warning: Use of the cutter driver is limited to a normal clinical environment (temperature 10–28°C;
pressure 700–1060hPa; humidity 30–75%).
Storage, Transport, and Use Conditions
Store the sterile packaged HawkOne catheter and cutter driver in a cool dry place until ready to use. Store and
transport the cutter driver within the following ranges: temperature, -29–60°C; pressure, 700–1060hPa; and
humidity, less than 85%.
Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based uids.
Warning: This device is not to be used in the presence of combustible or ammable gases, anesthetics,
cleaners, disinfectants, or in an oxygen-rich environment.
1
. The 30-day MAE-free
3,4
Directions for Use
Inspection
1. Before use, carefully inspect the HawkOne catheter and cutter driver to verify that the sterile packaging
and the devices are not damaged.
1
Ramiah et al. J Endovasc Ther 2006;13:592-602
2
Roberts D, Niazi K, Miller W, et al. CCI 2014 Jan 9. doi: 10.1002/ccd.25384.
3
Popma et al. Am J Cardiol 80: 19K-25K, 1997.
4
Werk et al. Circulation 118: 1358-1365, 2008.
3 Instructions for Use English
Caution: The HawkOne catheter (model numbers LS, LX, M, and S) and the cutter driver (model
number H1-14550) are not backward compatible with previously released models. See Table1 for
compatibility information.
2. Connect the HawkOne catheter to the cutter driver by inserting the proximal end of the catheter into the
cutter driver. Ensure that the thumb switch aligns with the slot in the cutter driver. When fully inserted, the
catheter connector locks into the cutter driver.
Caution: Do not attempt to disconnect the catheter from the cutter driver after they are connected
and locked. Disconnecting the catheter from the cutter driver after locking damages the system,
making it non-functional.
Note: If the HawkOne catheter or the cutter driver need replacement after the cutter driver is connected to
the catheter, replace both the cutter driver and the catheter.
Note: To avoid accidentally activating the cutter driver, be sure the thumb switch is fully advanced distally
to the O position before inserting the catheter into the cutter driver.
3. To conrm functionality of the HawkOne catheter, advance and retract the thumb switch. Verify that the
motor turns on and o, that the inner cutter moves freely, and the catheter tip deects and returns to its
original conguration as the cutter window is opened and closed. Advance the thumb switch to close the
cutter window and turn the motor o.
Note: The automatic motor control feature of the cutter driver can be disabled by using the main power
switch. When the switch is up, the automatic motor control is enabled. When the switch is down, the
thumb switch can be advanced and retracted without activating the motor.
4. Inspect the shaft, cutter housing and distal tip for sharp edges or protrusions. Do not use the catheter if a
sharp edge or a protrusion is detected.
Caution: Do not sharply bend or kink the HawkOne catheter shaft during handling. Sharply bending
or kinking the catheter shaft could damage the device and impair its function.
5. Check the catheter shaft for functionality of the hydrophilic coating. When wetted with sterile saline, the
catheter shaft feels slippery.
Note: To facilitate catheter handling, the most proximal portion of shaft is not coated.
6. If the catheter becomes kinked or damaged during use, replace the damaged catheter, together with the
cutter driver with a new system and return the used system to Medtronic for evaluation.
Preparation
1. Purge air from the catheter.
a. Fill a syringe (3cc or larger) with heparinized saline.
b. Ensure that the main power switch on the cutter driver is turned to the O position. Retract the thumb
switch to the On position to expose the cutter within the cutter window.
c. Flush the HawkOne catheter shaft by attaching the heparinized saline-lled syringe to the HawkOne
catheter ush port. Gently apply pressure to the syringe until all air has been ushed from the HawkOne
catheter and saline is seen exiting the cutter window.
d. Fully advance the thumb switch to the O and closed position.
e. Submerge the catheter tip in saline and wet the entire catheter length to activate the hydrophilic
coating.
f. Slide the distal ush tool from the proximal to the distal end of the catheter and gently seat the distal
ush tool when it comes to a stop at the distal end.
Note: When the distal ush tool is seated, the ush window in the catheter tip is visible outside the
distal ush tool distal seal.
Distal ush window
Figure 2. Distal ush tool, seated over the catheter tip
g. Rotate the distal end of the tip 180° clockwise to open the ush window. Point tip away from all
individuals and cover with cloth to avoid spray.
h. Fill a syringe (10cc recommended) with saline and attach the syringe to the luer lock on the distal ush
tool.
i. Retract the thumb switch to the On position to expose the cutter within the cutter window.
j. Flush the tip until uid exits the distal end of the tip.
k. Fully advance the thumb switch until the cutter window is closed and the thumb switch is in the O
position.
l. Rotate the distal end of the tip back to the closed position until the guidewire lumens are aligned.
Caution: Do not attempt to remove the distal ush tool from the catheter. Removing the distal
ush tool damages the catheter, making it non-functional.
m. Slide the distal ush tool back to the proximal end of the catheter.
n. Turn the main power switch of the cutter driver to the On position.
Insertion and Use
Once prepared, the catheter is ready for insertion into the patient.
1. Insertion
a. Prepare the patient and administer the appropriate anticoagulant and vasodilator therapy for standard
percutaneous intervention.
b. Insert the sheath and hemostasis valve using standard techniques.
Caution: Refer to Table1 for recommended sheath size requirements. Using smaller than
recommended sheaths can compromise device performance.
c. Locate the target lesion using angiographic assessment of the vessel.
d. If severe calcium is detected in the treatment area, use the SpiderFX embolic protection device with
the HawkOne catheter. Refer to the SpiderFX™ Instructions for Use for appropriate lter sizing and
deployment instructions.
Caution: When using the SpiderFX™ device in combination with the HawkOne catheter, the
SpiderFX™ lter must be deployed with the proximal radiopaque marker placed no less than 7cm
(for M and S use), 8cm (for LS use), or 11cm (for LX use) distal to the lesion. Failure to place the
lter appropriately can compromise device performance.
e. Using standard technique, place a guidewire across the target lesion. If using the SpiderFX device, the
capture wire will act as the primary guidewire for the HawkOne catheter.
Note: Refer to the vessel range specications in Table1 for HawkOne™ minimum vessel diameters
compatible with the HawkOne catheter model in use.
f. Ensure that the thumb switch is fully advanced in its closed and O position.
g. Carefully backload the end of the guidewire through the tip of the HawkOne™ catheter, making sure
that the guidewire travels through both distal and proximal guidewire lumens and exits proximal to
the cutter.
Caution: The guidewire must go through both lumens; otherwise, the distal ush window on the
tip could be open. Operating the device with the distal ush window open could result in the
embolization of excised tissue.
h. Loosen the hemostasis valve (if applicable) and carefully insert the HawkOne catheter into the sheath.
i. During insertion, hold the device close to the sheath hub and ensure axial alignment of the catheter tip
with the hemostasis valve.
Caution: Do not use excessive force, pinch, or bend the tip of the catheter when inserting the
catheter through the hemostasis valve of the sheath. Using excessive force, pinching, or bending
the tip can damage the device and impair its function.
j. Retighten the hemostasis valve (if applicable) to prevent blood loss.
Caution: If using a Tuohy-Borst sheath, do not over-tighten the Tuohy-Borst hemostasis valve.
Overtightening the Tuohy-Borst hemostasis valve may inhibit smooth advancement and rotation
of the HawkOne catheter or damage the shaft.
2. Lesion Treatment
a. Using uoroscopic guidance, carefully advance the HawkOne catheter to the proximal edge of the
target lesion.
Warning: Always use direct uoroscopic observation when manipulating the HawkOne catheter
in the peripheral vessels. If resistance is met during manipulation, determine the cause of
resistance before proceeding.
Warning: Never advance the distal tip of the HawkOne catheter near the oppy end of the
guidewire. If the HawkOne catheter is advanced to this position, it can cause the guidewire to
buckle into a loop when retracting the catheter. If buckling occurs, remove the catheter and
guidewire together to prevent potential damage to vessel walls. If resistance is still felt, remove
the sheath together with the guidewire and catheter.
Warning: Avoid excessive movement of the HawkOne catheter within the vessel at all times.
Excessive movement could result in embolization or vessel damage. In addition, excessive
catheter manipulation while the cutter window is open could result in embolization of previously
excised tissue fragments.
Warning: The cutter section of the HawkOne catheter is a rigid component. Vessel trauma or
device failure can result if excessive force or torque is used to advance the catheter.
Warning: Do not use the HawkOne catheter in bends in excess of 90°. Using in bends in excess of
90° can result in device failure.
Note: If the HawkOne catheter cannot be advanced across the lesion, consider carefully removing the
HawkOne catheter and predilating the lesion with a small diameter balloon angioplasty catheter.
b. Carefully rotate the HawkOne catheter cutter window toward the treatment site. Perform additional
angiographic assessment to conrm catheter position in relation to the lesion.
Note: The cutter housing surrounding the cutter and the entire distal tip are radiopaque to facilitate
angiographic visualization of the device orientation.
Anterior/
Right
Posterior
Proximal
Distal
7Fr cutter housing
LS and LX models
Caution: Do not torque the catheter shaft more than 360° in one direction. Torquing the catheter
shaft more than 360° in one direction could result in tip fracture or other device failure. If the
HawkOne catheter is not rotating easily, reposition the catheter or predilate the lesion.
c. To begin directional atherectomy, retract the thumb switch to expose the rotating blade and deect
the catheter tip.
Note: When advancing or retracting the thumb switch, the switch must be moved until a “click” is felt.
Feeling the “click” indicates that the catheter has achieved its fully retracted or fully advanced position.
Warning: Operating the device with the blade partially opened or closed could result in vessel
trauma or possible embolization of previously excised tissue.
d. With the motor running, slowly advance the HawkOne catheter through the target lesion under
uoroscopic guidance.
Caution: The cutter driver is not designed for continuous operation. Do not run the cutter driver
for more than 15minutes in any 30minute period.
Warning: When using the SpiderFX™ device in combination with the HawkOne catheter, never
advance the distal tip of the HawkOne catheter near the proximal radiopaque marker band of the
SpiderFX device. Contact with the marker band can result in distal embolization of the captured
debris, as well as vessel trauma or device failure.
Reference Table3 for the length of cut that can be completed for the corresponding catalog number.
Recommended cut speed is 2mm/sec.
Table3. Length of cut
Catalog number Length of cut Catalog number Length of cut
H1-LS 50mm H1-S 40mm
H1-LX 75mm H1-M 40mm
Ensure that remaining storage capacity of the tip is not exceeded during subsequent passes. Determine
if the tip is full based on the tactile feel of the thumb switch and by using uoroscopic guidance to
assess how far the cutter travels into the tip.
Warning: Exceeding the recommended maximum length or storage capacity of the catheter
tip before removing and emptying the device increases the risk of embolized excised tissue
fragments.
Note: If using the SpiderFX device, use regular uoroscopic observation to verify that the lter
is not occluded with debris, resulting in slow or no ow. If the lter becomes occluded or ow is
compromised, remove the HawkOne catheter and recover the lter. Once recovered, the lter cannot
be reintroduced into the body. Deploy a new lter per the SpiderFX™ embolic protection device
Instructions for Use.
e. Stop advancing the catheter upon reaching the end of the target segment. Carefully advance the
thumb switch to close the cutter and turn o the cutter driver. Cutter closure is indicated by a tactile
“click.”
Warning: If the HawkOne catheter does not advance easily, close the cutter by advancing the
thumb switch. Do not use excessive force to advance the thumb switch. Assess whether device
repositioning or predilation is required.
f. After reaching the end of the target segment, use a combination of angiographic or intravascular
ultrasound imaging to assess the extent of directional atherectomy.
Note: If using the SpiderFX device, verify that the lter has not become occluded with debris, before
making additional cutting passes with the HawkOne catheter.
g. If there is adequate storage capacity remaining in the tip, the HawkOne catheter can be readvanced
and positioned for the additional cut by repeating steps2a through 2f (see the following note).
Note: If the thumb switch cannot be fully advanced (after completing a cut), the tip could be at full
capacity. Proceed to the following “Catheter Removal” and “Tissue Removal” steps.
3. Catheter Removal
a. Carefully remove the catheter from the patient under uoroscopic guidance.
b. Perform nal angiographic or intravascular ultrasound evaluation after HawkOne catheter treatment.
4. Tissue Removal
a. Remove the catheter from the 0.36mm (0.014in) guidewire.
b. Fully advance the thumb switch to the closed and O position. Turn the main power switch on the
cutter driver to the O position.
c. Gently wipe down the outside of the tip and catheter with wet gauze.
d. Slide the distal ush tool from the proximal end to the distal end of the catheter and gently seat the
ush tool against the hard stop at the distal end.
Note: Verify that the ush window is visible outside of the seal.
Left
Proximal
Distal
Figure3. Cutter housing
Anterior/
Right
Posterior
6Fr cutter housing
M and S models
Left
Distal ush window
Figure4. Distal ush tool, seated over the catheter tip
e. Rotate the distal end of the tip 180° clockwise to open the ush window. Point the tip away from all
individuals and cover with a cloth to avoid spray.
f. Fill a syringe (10cc recommended) with saline and attach the syringe to the luer lock on the distal ush
tool.
g. Retract the thumb switch to the On position to expose the cutter within the cutter window.
h. Flush the tip with one constant stroke of 5–10cc/sec. (Repeat if necessary to remove tissue.)
i. Use tweezers to retrieve exposed tissue from the ush window if the tissue was not fully ushed from
the window.
Caution: Avoid using excessive force when removing tissue with tweezers to avoid damaging the
device.
j. Fully advance the thumb switch to the closed and O position.
k. Rotate the distal end of the tip back to the closed position until the guidewire lumens are aligned.
l. Slide the distal ush tool back to the proximal end of the catheter.
Caution: Do not attempt to remove the distal ush tool from the catheter. Removing the distal
ush tool damages the catheter, making it non-functional.
m. Turn the main power switch of the cutter driver to the On position.
5. Repeated Insertion and Use
a. If additional insertions are needed, repeat from step1cin “Insertion and Use”.
b. This cutting sequence can be repeated as necessary to achieve the desired degree of plaque excision.
Note: In vitro testing in severely calcied cadaver lesions has demonstrated minimal cutter wear after
cutting calcied lesions for a total length of 500mm. Device performance was maintained throughout
testing.
CAUTION: Cutting extended lengths in severely calcied lesions can result in cutter wear.
Encountering increased resistance during a cutting pass could indicate that the device needs to
be replaced.
Disposal
Warning: This device is supplied sterile for single use only. Do not reprocess or resterilize. Reprocessing
and resterilizing could increase the risk of patient infection and risk of compromised device
performance. If the packaging or the device are damaged, discard the unit.
Follow local governing ordinances and recycling plans regarding disposal or recycling of device components.
Do not incinerate the cutter driver, as the enclosed batteries can explode at excessive temperatures.
Caution: The cutter driver is a single use device. Do not open the cutter driver casing, modify the cutter
driver components, or change the cutter driver battery. Opening or modifying the cutter driver could
result in damage to the device or injury to the patient or physician.
The Batteries Directive, 2006/66/EC, introduces new requirements, as of September26, 2008, regarding
removability of batteries from waste equipment in EU Member States. To comply with this directive, this device
has been designed for safe removal of the batteries at device end-of-life by a waste treatment facility. Before
sending infected units for recycling, remove the battery from the cutter driver and decontaminate the infected
units to remove potential biohazards. To prevent risk of re, ensure that battery terminals are not electrically
shorted when decontaminating them. If it is not possible to decontaminate the unit for recycling, do not
attempt to remove the batteries from waste equipment. Repeated disposal of small amounts of portable
batteries to landll and incineration is allowed under the Batteries Directive and Member State regulations.
Electromagnetic Compatibility Limits
This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive
93/42/EEC (EN55011 ClassA and EN60601-1-2), the IEC60601-1:2012 (3.1Edition), and the IEC60601-2, 2014
(4th Edition). The cutter driver needs special precautions regarding electromagnetic compatibility (EMC) to
ensure it is installed and put into service according to the EMC information provided in this document. The
cutter driver can radiate radio frequency energy, and operators could experience harmful interference to or
from other devices (test by turning the cutter driver o and on). Correct the interference by reorienting or
relocating the receiving device, increasing the separation between devices, or consulting the manufacturer of
the equipment experiencing the interference.
Table4. Guidance and manufacturers declaration – electromagnetic emissions
The cutter driver is intended for use in an electromagnetic environment as specied in the following
guidance. The customer or the user of the cutter driver must ensure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CISPR11
Warning: Avoid using this equipment if it is adjacent to, or stacked with, other equipment. Such use
could cause this equipment to operate improperly. If this equipment must be set up adjacent to, or
stacked with, other equipment, verify that all the equipment is operating properly.
Warning: Use of accessories, transducers, and cables (other than those specied or provided by
Medtronic) could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment, and could result in improper operation.
Warning: Use portable RF communication equipment (including cables specied by Medtronic or
peripherals given as antenna cables and external antennas) no closer than 30cm (12in) of any part of
the HawkOne™ directional atherectomy system. If the communication equipment is too close to the
HawkOne™ system, the system’s per formance could be compromised.
Table5. Guidance and manufacturers declaration – electromagnetic immunity
The cutter driver is intended for use in an electromagnetic environment as specied in the following
guidance. The customer or the user of the cutter driver must ensure that it is used in such an
environment.
Immunity test IEC60601 test
Electrostatic
discharge (ESD)
IEC61000-4-2
NOTE1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects, and people.
a) The ISM (industrial, scientic and medical) bands between 150kHz and 80MHz are 6.765MHz to
6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz.
b) The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency
range 80MHz to 2.5GHz are intended to decrease the likelihood of interference from mobile and portable
communications equipment in case they are inadvertently brought into patient areas. For this reason, an
additional factor of 10:3 has been incorporated into the formulae used in calculating the recommended
separation distance for transmitters in these frequency ranges.
c) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. Consider conducting an electromagnetic site survey to assess the impact of
xed RF transmitters on the electromagnetic environment. If the measured eld strength in the location
where the cutter driver is used exceeds the applicable RF compliance level as dened in Table5, observe
the system to verify normal operation. If abnormal performance is observed, attempt additional measures,
such as reorienting or relocating the cutter driver.
d) Ensure that eld strengths are less than 3V/m over the frequency range 150kHz to 80MHz.
ClassA Group1 The cutter driver is suitable for use in a typical hospital
level
± 8kV contact ± 8kV contact Floors should be wood, concrete, or ceramic tile.
± 15kV air ± 15kV air
environment.
Compliance
level
Electromagnetic environment guidance
If oors are covered with synthetic material, the
relative humidity should be at least 30%.
4EnglishInstructions for Use
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