Medtronic THP-S Instructions for Use

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TurboHawk™ Plus

Directional Atherectomy System

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

HawkOne™, SilverHawk™, SpiderFX™, TurboHawk™

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Symbol definitions

Main power On

Manufactured in

Do not resterilize

Main power Off

Quantity

Secondary power On

Package quantity

Secondary power Off

Catheter lock release

Sterilized using irradiation

Sterilized using ethylene oxide

Do not reuse

For prescription use only

Do not use if package is damaged

Consult instructions for use at this website

Follow instructions for use. Symbol appears blue on device

Atmospheric pressure limitation

Humidity limitation

Temperature limit

Keep away from sunlight

Keep dry

WEEE (Waste from electrical and electronic equipment)

Defibrillation-proof, type CF applied part

Non-ionizing electromagnetic radiation

Effective length

Maximum profile

Tip length

Vessel range

Compatible guidewire

Recommended sheath

Catalog number

Manufacturer

Date of manufacture

Use-by date

Batch code

For US audiences only

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1 Device description

The TurboHawk Plus directional atherectomy system (TurboHawk Plus catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the TurboHawk Plus catheter with the SpiderFX embolic protection device mitigates risk of distal embolization that can be generated when heavily calcified plaque breaks down. (For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device.)

The TurboHawk Plus catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. The distal end of the TurboHawk Plus catheter is comprised of a small cutting unit with an inner blade that rotates within a tubular housing. The proximal end of the TurboHawk Plus catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number FG02550) is a battery-driven, internally powered device, designed to power the TurboHawk Plus directional atherectomy catheter.

The TurboHawk Plus directional atherectomy system has two switches: 1) the cutter positioning lever (thumb switch) on the TurboHawk Plus catheter (Figure 1); and 2) the main power switch on the cutter driver (Figure 2). 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 TurboHawk Plus catheter activates the drive shaft and the cutter. With the cutter engaged, the TurboHawk Plus 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 TurboHawk Plus catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the TurboHawk Plus catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

Figure 1. Illustration and nomenclature

1 Cutter positioning lever (thumb switch) 2 Flush port 3 Torque knob 4 Strain relief 5 Distal flush tool

Figure 2. Cutter driver

1 Main power switch 2 Catheter lock release button

6 Shaft 7 Cutter window 8 Proximal tip (nose cone) 9 Distal flush window

10 Distal tip

3 Catheter connector 4 Insertion point for catheter

2 Device compatibility

The TurboHawk Plus cutter driver (catalog number FG02550) is not compatible with the HawkOne catheters. It is designed to work with the TurboHawk Plus catheter models listed in Table 1 .

Warning: The TurboHawk Plus catheter may only be used with the FG02550 cutter driver. The TurboHawk Plus catheter is not physically compatible with the H1-14550 cutter driver. Attempting to use the TurboHawk Plus catheter with the H1-14550 cutter driver may result in loss of functionality and damage to the catheter.

TurboHawk Plus system specifications and cutter driver compatibility

Table 1.

Specification Catalog number

Product catalog number

Model: LS LX M S Compatible cutter

driver: Effective length: 107 cm 104 cm 129 cm 145 cm Tip length: 6.6 cm 9.6 cm 5.9 cm 5.9 cm Maximum catheter

profile: Recommended

sheath size:

Maximum guidewire diameter:

Vessel range: 3.5–7.0 mm 3.5–7.0 mm 3.0–7.0 mm 2.0–4.0 mm Nominal voltage: 6 V 6 V 6 V 6 V

Note: The cutter driver is protected against electrical shock (defibrillation-proof type, CF). Keep the cutter driver dry (IPX0).

THP-LS THP-LX THP-M THP-S

FG02550 FG02550 FG02550 FG02550

2.6 mm 2.6 mm 2.2 mm 2.2 mm

7 Fr 7 Fr 6 Fr 6 Fr

(2.5 mm) (2.5 mm) (2.2 mm) (2.2 mm)

0.36 mm 0.36 mm 0.36 mm 0.36 mm

(0.014 in) (0.014 in) (0.014 in) (0.014 in)

3 Indications for use

The TurboHawk Plus directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Plus catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The TurboHawk Plus catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

4 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

5 Warnings

• The TurboHawk Plus catheter may only be used with the FG02550 cutter driver. The TurboHawk Plus catheter is not physically compatible with the H1-14550 cutter driver. Attempting to use the TurboHawk Plus catheter with the H1-14550 cutter driver may result in loss of functionality and damage to the catheter.

• Pair the SpiderFX embolic protection device with the TurboHawk Plus catheter when used in complex, hard, calcified lesions. Pairing the SpiderFX device with the TurboHawk Plus 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 TurboHawk Plus catheter should only be used by physicians trained in percutaneous peripheral interventional procedures.

• Limit the use of this device to facilities where surgical support is readily available in the event of a serious complication.

• Do not use the device after the labeled “Use-by” expiration date.

• Use of the cutter driver is limited to a normal clinical environment (temperature 10–28°C; atmospheric pressure 700–1060 hPa; humidity 30–75%).

• Do not use this device in the presence of combustible or flammable gases, anesthetics, cleaners, disinfectants, or in an oxygen-rich environment.

• This device was designed for single use only. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing, or resterilization may compromise the device performance and structural integrity, or create a risk of contamination, which could result in patient injury, illness, or death.

• Always use direct fluoroscopic observation when manipulating the TurboHawk Plus catheter in the peripheral vessels. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

• Never advance the distal tip of the TurboHawk Plus catheter near the floppy end of the guidewire. If the TurboHawk Plus 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.

• Avoid excessive movement of the TurboHawk Plus 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 TurboHawk Plus 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 TurboHawk Plus catheter in bends in excess of 90°. Using the catheter in bends in excess of 90° can result in device failure.

• 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 TurboHawk Plus catheter, never advance the distal tip of the TurboHawk Plus 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 TurboHawk Plus 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 30 cm (12 in) of any part of the TurboHawk Plus directional atherectomy system. If the communication equipment is too close to the TurboHawk Plus system, the system’s performance could be compromised.

6 Precautions

• Carefully inspect the sterile package and the device before use. Do not use the device if the packaging or the device is damaged.

• The TurboHawk Plus catheter (model numbers LS, LX, M, and S) and the cutter driver (model number FG02550) are not compatible with the HawkOne catheter and cutter driver (model number H1-14550). See Table 1 for compatibility information.

• Do not sharply bend or kink the TurboHawk Plus 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 nonfunctional.

• Refer to Table 1 for recommended sheath size requirements. Using sheaths that are smaller than the recommended size can compromise device performance.

• When using the SpiderFX device in combination with the TurboHawk Plus catheter, the SpiderFX filter must be deployed in such a way that the proximal radiopaque marker is no less than 7 cm (for M and S use), 8 cm (for LS use), or 11 cm (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 could 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 TurboHawk Plus 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 TurboHawk Plus 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 15 minutes in any 30 minute 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.

• Dispose of the device in accordance with applicable laws, regulations, and hospital procedures, including those regarding biohazards, microbial hazards, and infectious substances.

• 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.

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• Do not use the device in proximity to known sources of electromagnetic disturbance such as radio-frequency identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic article surveillance), near-field communications (NFC) systems, wireless power transfer (WPT) and unique medical emitters such as electrocautery, MRI, electrosurgical units, and diathermy equipment. Operating near these devices may lead to device malfunction.

7 Potential adverse events

The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following conditions:

• 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

8 Summary of DEFINITIVE Ca++ study

The following DEFINITIVE Ca++ study data are for the previously released SilverHawk and TurboHawk plaque excision systems. Although the TurboHawk Plus directional atherectomy system was not part of the study, it is similar in design to the clinically evaluated plaque excision systems. Thus, the Definitive Ca++ study data provides clinical insight into how the TurboHawk Plus device is expected to perform.

DEFINITIVE Ca++ was a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the SilverHawk and TurboHawk plaque excision systems and the SpiderFX embolic protection device for the treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral or popliteal arteries. An independent angiographic core laboratory and a Clinical Events Committee (CEC) were employed to ensure unbiased review and classification of events and endpoints. A total of 133 subjects from 17 centers were enrolled. A summary of safety and effectiveness data is provided in Table 2.

Table 2. DEFINITIVE Ca++ summary of safety and effectiveness

Angiographic core

Parameters Site reported results

laboratory reported

results

Baseline Demographics

Age (mean ± SD) 69.7 ± 9.8 Male 71.4% (95/133) Severe calcification 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 effectiveness 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 (grade C) 0.0% (0/131) Dissection, target vessel (grade D 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 revasculari-

zation

The proportion of subjects event-free (per angiographic core laboratory review and CEC adjudication) after 30 days was compared to a performance goal of 85.5% based on the TALON registry1. The 30-day MAE-free rate was 93.1% (122/131). The 95% lower confidence 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 effectiveness endpoint was successful revascularization of the target vessel (defined 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 effectiveness criterion (≤ 50% residual diameter stenosis) was achieved in 92.0% (150/163) of lesions. The lower bound of the confidence interval is 87.6%. Therefore, the effectiveness 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 effectiveness performance goal was based on site-reported residual diameter stenosis from the TALON registry. The differences between site-assessed 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 confidence interval is 93.8%, which is above the 90% performance goal that was derived from the TALON site-reported data.

3,4

0.0% (0/131)

9 How supplied

The catheter and cutter driver are packaged and sterilized individually, and are shipped in two shelf cartons. Both are intended for single patient use only.

Ramiah et al. J Endovasc Ther 2006;13:592-602

Roberts D, Niazi K, Miller W, et al. CCI 2014 Jan 9. doi: 10.1002/ccd.25384.

Popma et al. Am J Cardiol 80: 19K-25K, 1997.

Werk et al. Circulation 118: 1358-1365, 2008.

10 Storage, transport, and use conditions

Store the sterile packaged catheter and cutter driver in a dry area away from sunlight until ready to use. Store and transport the cutter driver within the following ranges: temperature, -29–60°C; atmospheric pressure, 700–1060 hPa; and humidity, less than 85%.

Warning: Use of the cutter driver is limited to a normal clinical environment (temperature 10–28°C; atmospheric pressure 700–1060 hPa; humidity 30–75%).

Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids.

Warning: Do not use this device in the presence of combustible or flammable gases, anesthetics, cleaners, disinfectants, or in an oxygen-rich environment.

11 Directions for use

Warning: This device was designed for single use only. Do not reuse, reprocess, or resterilize this device.

Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination, which could result in patient injury, illness, or death.

11.1 Inspection

1. Before use, carefully inspect the catheter and cutter driver to verify that the sterile packaging and the devices are not damaged.

Caution: Carefully inspect the sterile package and the device before use. Do not use the device if the packaging or the device is damaged.

2. Connect the TurboHawk Plus 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 (Figure 2). When fully inserted, the catheter connector locks into the cutter driver. To remove the catheter from the cutter driver, depress the catheter lock release button (Figure 2) and pull the catheter from the cutter driver.

Caution: The TurboHawk Plus catheter (model numbers LS, LX, M, and S) and the cutter driver (model number FG02550) are not compatible with the HawkOne catheter and cutter driver (model number H1-14550). See Table 1 for compatibility information.

Note: To avoid accidentally activating the cutter driver, be sure the thumb switch is fully advanced distally to the Off position before inserting the catheter into the cutter driver.

3. To confirm functionality of the TurboHawk Plus catheter, advance and retract the thumb switch. Verify that the motor turns on and off, and the inner cutter moves freely. As shown in Figure 3, also verify that the catheter tip deflects (2) and returns to its original configuration (1) as the cutter window position is opened and closed. Advance the thumb switch to close the cutter window and turn the motor off.

Figure 3. Cutter window positions

1 Cutter window closed 2 Cutter window open with tip deflected

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 TurboHawk Plus 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.

11.2 Preparation

• Purge air from the catheter

1. Fill a syringe (3 mL or larger) with heparinized saline.

2. Ensure that the main power switch on the cutter driver is turned to the Off position. Retract the thumb switch to the On position to expose the cutter within the cutter window.

3. Flush the TurboHawk Plus catheter shaft by attaching the heparinized saline-filled syringe to the TurboHawk Plus catheter flush port. Gently apply pressure to the syringe until all air has been flushed from the TurboHawk Plus catheter and saline is seen exiting the cutter window.

4. Fully advance the thumb switch to the Off and closed position.

5. Submerge the catheter tip in saline and wet the entire catheter length to activate the hydrophilic coating.

6. Slide the distal flush tool from the proximal to the distal end of the catheter and gently seat the distal flush tool when it comes to a stop at the distal end.

Note: When the distal flush tool is seated, the flush window in the catheter tip is visible outside the distal flush tool distal seal.

Figure 4. Distal flush tool, seated over the catheter tip

1 Distal flush window

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7. Rotate the distal end of the tip 180° clockwise to open the flush window. Point the tip away from all individuals and cover with cloth to avoid spray.

8. Fill a syringe (10 mL recommended) with saline and attach the syringe to the luer lock on the distal flush tool.

9. Retract the thumb switch to the On position to expose the cutter within the cutter window.

10. Flush the tip until fluid exits the distal end of the tip.

11. Fully advance the thumb switch until the cutter window is closed and the thumb switch is in the Off position.

12. 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 flush tool from the catheter. Removing the distal

flush tool damages the catheter, making it nonfunctional.

13. Slide the distal flush tool back to the proximal end of the catheter.

14. Turn the main power switch of the cutter driver to the On position.

11.3 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 Table 1 for recommended sheath size requirements. Using sheaths that are

smaller than the recommended size 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 TurboHawk Plus catheter. Refer to the SpiderFX Instructions for use for appropriate

filter sizing and deployment instructions.

Caution: When using the SpiderFX device in combination with the TurboHawk Plus catheter,

the SpiderFX filter must be deployed with the proximal radiopaque marker placed no less than

7 cm (for M and S use), 8 cm (for LS use), or 11 cm (for LX use) distal to the lesion. Failure to

place the filter 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 TurboHawk Plus catheter.

Note: Refer to the vessel range specifications in Table 1 for minimum vessel diameters that are

compatible with the applicable TurboHawk Plus catheter catalog number.

f. Ensure that the thumb switch is fully advanced in its closed and Off position.

g. Carefully backload the end of the guidewire through the tip of the TurboHawk Plus 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 flush window on

the tip could be open. Operating the device with the distal flush window open could result in the

embolization of excised tissue. h. Loosen the hemostasis valve (if applicable) and carefully insert the TurboHawk Plus 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 TurboHawk Plus catheter or damage the shaft.

2. Lesion treatment a. Using fluoroscopic guidance, carefully advance the TurboHawk Plus catheter to the proximal

edge of the target lesion. Warning: Always use direct fluoroscopic observation when manipulating the TurboHawk Plus

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 TurboHawk Plus catheter near the floppy end of the guidewire. If the TurboHawk Plus 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 TurboHawk Plus 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 TurboHawk Plus 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 TurboHawk Plus catheter in bends in excess of 90°. Using the catheter in bends in excess of 90° can result in device failure.

Note: If the TurboHawk Plus catheter cannot be advanced across the lesion, consider carefully removing the TurboHawk Plus catheter and predilating the lesion with a small diameter balloon angioplasty catheter.

b. Carefully rotate the TurboHawk Plus catheter cutter window toward the treatment site. Perform

additional angiographic assessment to confirm the 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. Figure 5. Cutter housing

1 Right 2 Anterior / Posterior 3 Left 4 Proximal

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 TurboHawk Plus 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

deflect 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 TurboHawk Plus catheter through the target lesion

under fluoroscopic guidance. Caution: The cutter driver is not designed for continuous operation. Do not run the cutter driver

for more than 15 minutes in any 30 minute period. Warning: When using the SpiderFX device in combination with the TurboHawk Plus catheter,

never advance the distal tip of the TurboHawk Plus 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 Table 3 for the length of cut that can be completed for the corresponding catalog number. Recommended cut speed is 2 mm/s.

Table 3. Length of cut

3. Catheter removal

4. Tissue removal

Catalog number Length of cut

THP-LS 50 mm THP-LX 75 mm

THP-S 40 mm THP-M 40 mm

Ensure that the 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 fluoroscopic 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 fluoroscopic observation to verify that the filter is not occluded with debris, resulting in slow or no-flow. If the filter becomes occluded or flow is compromised, remove the TurboHawk Plus catheter and recover the filter. Once recovered, the filter cannot be reintroduced into the body. Deploy a new filter 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 off the cutter driver. Cutter closure is indicated by a tactile “click.”

Warning: If the TurboHawk Plus 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 filter has not become occluded with debris,

before making additional cutting passes with the TurboHawk Plus catheter.

g. If there is adequate storage capacity remaining in the tip, the TurboHawk Plus catheter can be

readvanced and positioned for the additional cut by repeating steps 2a 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 Step 3 Catheter removal and Step 4 Tissue removal.

a. Carefully remove the catheter from the patient under fluoroscopic guidance. b. Perform final angiographic or intravascular ultrasound evaluation after the TurboHawk Plus

catheter treatment.

a. Remove the catheter from the 0.36 mm (0.014 in) guidewire. b. Fully advance the thumb switch to the closed and Off position. Turn the main power switch on

the cutter driver to the Off position. c. Gently wipe down the outside of the tip and catheter with wet gauze. d. Slide the distal flush tool from the proximal end to the distal end of the catheter and gently seat

the flush tool against the hard stop at the distal end.

Note: Verify that the flush window is visible outside of the seal.

Figure 6. Distal flush tool, seated over the catheter tip

1 Distal flush window

e. Rotate the distal end of the tip 180° clockwise to open the flush window. Point the tip away from

all individuals and cover with a cloth to avoid spray.

f. Fill a syringe (10 mL recommended) with saline and attach the syringe to the luer lock on the

distal flush 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 5–10 mL per second. (Repeat if necessary to remove

tissue.)

i. Use tweezers to retrieve exposed tissue from the flush window if the tissue was not fully flushed

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 Off position.

k. Rotate the distal end of the tip back to the closed position until the guidewire lumens are

aligned.

l. Slide the distal flush tool back to the proximal end of the catheter.

5 Distal 6 7 Fr cutter housing LS and LX models 7 6 Fr cutter housing M and S models

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Caution: Do not attempt to remove the distal flush tool from the catheter. Removing the distal flush tool damages the catheter, making it nonfunctional.

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 the process from Step 1c in 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 calcified cadaver lesions has demonstrated minimal cutter

wear after cutting calcified lesions for a total length of 500 mm. Device performance was maintained throughout the testing.

Caution: 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.

12 Disposal

Caution: Dispose of the device in accordance with applicable laws, regulations, and hospital procedures,

including those regarding biohazards, microbial hazards, and infectious substances.

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.

13 Electromagnetic compatibility limits

This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class A and EN 60601-1-2), the IEC 60601-1:2012 (3.1 Edition), and the IEC 60601-1-2:2014 (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 off 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.

Table 4. Guidance and manufacturers declaration – electromagnetic emissions

The cutter driver is intended for use in an electromagnetic environment as specified 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

RF emissions CISPR 11 Class A Group 1 The cutter driver is suitable for

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 specified 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 specified by Medtronic or peripherals given as antenna cables and external antennas) no closer than 30 cm (12 in) of any part of the TurboHawk Plus directional atherectomy system. If the communication equipment is too close to the TurboHawk Plus system, the system’s performance could be compromised.

Caution: Do not use the device in proximity to known sources of electromagnetic disturbance such as radio-frequency identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic article surveillance), near-field communications (NFC) systems, wireless power transfer (WPT) and unique medical emitters such as electrocautery, MRI, electrosurgical units, and diathermy equipment. Operating near these devices may lead to device malfunction.

Guidance and manufacturers declaration – electromagnetic immunity

Table 5.

Immunity test IEC 60601 test level Compliance level Electromagnetic envi-

Electrostatic discharge (ESD)

IEC 61000-4-2 ±15 kV air ±15 kV air

Radiated RF 3 V/m 80 MHz to IEC 61000-4-3

Conducted Immunity IEC 61000-4-6

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

±8 kV contact ±8 kV contact Floors should be wood,

2.7 GHz

3 V/m 80 MHz to

2.7 GHz

80% AM at 1 kHz 80% AM at 1 kHz

Spot frequencies 385 MHz – 5.785 GHz Pulse modulation

3 V

& 6 V

RMS

150 kHz – 80 MHz 150 kHz – 80 MHz ISM band I/O ports ISM band I/O ports

RMS

Spot frequencies 385 MHz – 5.785 GHz Pulse modulation

3 V

RMS

30 A/m 30 A/m Ensure that power fre-

guidance

use in a typical hospital environment.

ronment guidance

concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Use portable and mobile RF communications equipment no closer than the recommended separation distance to any part of the cutter driver. The recommended separation distance can be calculated from the equation applicable to the frequency of the transmitter. The recommended separation distance is a minimum of 0.2 meter for transmitters of 80 MHz to

2.5 GHz. Interference may occur in the vicinity of equipment marked with the following symbol:

& 6 V

RMS

quency magnetic fields are at levels characteristic of a

Table 5. Guidance and manufacturers declaration – electromagnetic immunity (continued)

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people. a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to

6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency

range 80 MHz to 2.5 GHz 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 fixed 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 fixed RF transmitters on the electromagnetic environment. If the measured field strength in the location where the cutter driver is used exceeds the applicable RF compliance level as defined in Table 5, 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 field strengths are less than 3 V/m over the frequency range 150 kHz to 80 MHz.

Table 6. Recommended separation distances between portable and mobile RF communications equipment and the cutter driver

The cutter driver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the cutter driver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system.

Rated maximum out-

put power of transmit-

ter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

typical location in a typical hospital environment.

0.01 0.12 m 0.12 m 0.23 m

0.1 0.37 m 0.37 m 0.74 m 1 1.17 m 1.17 m 2.3 m

10 3.70 m 3.70 m 7.4 m

100 11.70 m 11.70 m 23.3 m NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

14 About this manual

Read this manual and follow its instructions carefully. The words Warning, Caution, and Note convey special meanings. Carefully review these instructions when they are used throughout this manual to ensure safe and effective operation of this product.

Warning: A Warning indicates that the personal safety of the patient or physician may be involved. Disregarding a Warning could result in injury to the patient or physician.

Caution: A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the product.

Note: A Note indicates special information to facilitate use of the product, or to clarify important information.

15 Disclaimer of warranty

Important: This disclaimer of warranty does not apply in any countries where such a disclaimer is not

permitted by law.

The warnings contained in the product labeling provide more detailed information and are considered an integral part of this disclaimer of warranty. Although the product has been manufactured under carefully controlled conditions, Medtronic has no control over the conditions under which this product is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct, incidental, or consequential damages caused by any use, defect, failure, or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has any authority to bind Medtronic to any representation or warranty with respect to the product.

The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.

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Medtronic, Inc.

*M003606C001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com

Medtronic Ireland

Parkmore Business Park West Galway Ireland