Diamondback 360™

Applies to Diamondback 360™ Peripheral Orbital Atherectomy System only: Including the Orbital Atherectomy Device (OAD) with GlideAssist™, Saline Pump, Viperwire Advance™ Peripheral Guide Wire, and Viperwire Advance™ with Flex Tip Peripheral Guide Wire

Applies to Diamondback 360™ Peripheral Orbital Atherectomy System –  Exchangeable Series only: Including the Orbital Atherectomy Device (OAD), Handle, Orbital Atherectomy Cartridge, Saline Pump, Viperwire Advance™ Peripheral Guide Wire, and Viperwire Advance™ with Flex Tip Peripheral Guide Wire
 

INDICATIONS

The Diamondback 360™  Peripheral Orbital Atherectomy System/Diamondback 360™  Peripheral Orbital Atherectomy System – Exchangeable Series (OAS) is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS Solid, Classic and Micro Crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.*

*The 2.00 Max Crown has not been tested to support removal of stenotic material from artificial dialysis fistulae (AV shunt).
 

CONTRAINDICATIONS

Use of the OAS is contraindicated in the following situations:

• The guide wire cannot be passed across the peripheral lesion.
• The system cannot be used in coronary arteries.
• The target lesion is within a bypass graft or stent.
• The patient has angiographic evidence of thrombus; thrombolytic therapy must be instituted prior to atherectomy.
• The patient has angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively to permit the dissection to heal before treating the lesion with the OAS.
   

WARNINGS

• Do not use the OAD in a vessel that is too small for the crown.  The reference vessel diameter at the treatment area must be at least 2.00 mm in diameter for the 1.25mm Micro crown.
• If mechanical failure of the OAD occurs before or during the atherectomy procedure, discontinue use immediately. Do not attempt to use a damaged OAD or other system component. Use of damaged components may result in system malfunction or patient injury.
• Do not use the OAD during spasm of the vessel.
• Only use approved and compatible Viperwire Advance™  guide wires. Reference the Instructions for Use for the appropriate guide wire to use based on the OAD shaft configuration. Follow CSI’s instructions related to guide wire use.
• Do not continue treatment if the guide wire or the OAD becomes sub-intimal.
• Immediately stop use if the OAD stalls.  Review for complications and mechanical failure if a stall condition occurs.  Do not change to a higher speed if the OAD stalls.
• Performing treatment in vessels or bifurcations that are excessively tortuous or angulated may result in vessel damage.
• Always use fluoroscopy when advancing the guide wire to avoid misplacement, dissection, or perforation. The OAD tracks over the guide wire, so it is imperative that the guide wire be initially placed through the stenotic lumen and not in a false channel.
• Do not inject contrast while OAD crown is spinning.  OAD failure or patient harm may occur.
• Do not attempt aspiration through the OAD or saline line while placed within the body. If saline is pulled out through the OAD or saline line, air may enter the system.
• If air is noticed in the system while the OAD is within the body, discontinue treatment by pressing the OAS Pump power button and carefully remove the OAD driveshaft and crown from the introducer sheath/guide catheter.
• Handle the OAD and guide wire carefully. A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use.
• Never operate the OAD without normal saline and lubricant solution. Flowing saline and lubricant solution is required for cooling and lubricating the OAD during use to avoid overheating and permanent damage to the OAD and possible patient injury.
• The crown at the distal tip of the OAD operates at very high speeds. Do not allow body parts or clothing to come into contact with the crown. Physical injury or entanglement may occur.
• Never advance the orbiting crown to the point of contact with the guide wire spring tip. Distal detachment and embolization of the tip may result.
• Always advance the orbiting, abrasive crown by using the crown advancer knob. Never advance the orbiting crown by advancing the shaft or handle. Guide wire buckling may occur, and perforation or vascular trauma may result.
• Always keep the crown advancing or retracting while it is at high rotational speeds. Do not allow the crown to remain in one location for more than 2–3 seconds. Maintaining the crown in one location while it is orbiting at high speeds may lead to excessive tissue removal.
• Do not start or stop orbiting of the crown when tight in a lesion.
• Never force the crown when rotational or translational resistance occurs; vessel perforation may occur. If resistance to motion is noted, retract the crown and stop treatment immediately. Use fluoroscopy to analyze the situation.
• When treating tight stenosis, create a channel at low or medium speed before traversing the lesion at high speed. Crossing a tight stenosis on high speed may cause the shaft and/or guide wire to fracture as a result of excessive force.
• While advancing the crown through the introducer sheath/guide catheter, do not activate crown rotation. The crown must not spin while located within the introducer sheath/guide catheter.
• Do not prolapse or bend the guide wire core.  If the spring tip becomes prolapsed, keep the bend/prolapse contained within the spring tip section only.  Spinning over a prolapsed or bent guide wire core can result in damage to the guide wire or OAD.
• The system should not be used on children or pregnant women.
• Do not re-use or re-sterilize the OAD.  If the OAD is re-used, the OAD may not function as intended and serious infection, leading to potential harm and/or death, may occur.
• Do not spin the crown in GlideAssist™ mode with the guide wire brake lever in the unlocked position, without first securing the guide wire by holding it with fingers or with the guide wire torquer.  If using the guide wire torquer, ensure that it is securely fastened to the guide wire before starting to spin the crown. Failure to secure the guide wire when the brake is unlocked could allow the guide wire to spin and/or migrate while in GlideAssist™ mode which may result in patient harm.
   

PRECAUTIONS

• Do not use the product if the sterile packaging appears damaged or the shelf life has expired.
• User should take precautions when using the OAS or its components in conjunction with other medical equipment 
• Do not flip contents of trays into the sterile field as damage may occur.  Components within trays must be carefully removed and placed into sterile field to avoid damage.
• Follow standard hospital atherectomy policies and procedures, including those related to anticoagulation and vasodilator therapy.
• Radiographic equipment for fluoroscopy should be used to provide high-resolution images. Guide wires and catheters should only be manipulated under fluoroscopy.
• Because of the torque responsiveness of ViperWire™ peripheral guide wires , they are more difficult to handle than other commercially available guide wires used in peripheral angioplasty. Exercise care when using these guide wires.
• Use only normal saline and lubricant solution as the infusate. (Drugs such as vasodilators are added to the infusate at the physician’s discretion). The OAD may malfunction if contrast or other substances are injected into the OAD infusion port.
• Do not operate the OAD without using recommended ViperSlide™ Lubricant concentration (maximum speeds may not be achieved without lubricants).
• Ensure the OAD strain relief remains straight during atherectomy treatment.
• To relieve compression in the driveshaft, lock the crown advancer knob at 1 cm from the full back position, advance device over the wire to a position proximal from the lesion, deploy the guide wire brake, then unlock the crown advancer knob and move it fully proximal.  If the OAD is started with existing compression in the driveshaft, it may result in the crown springing forward.
• If 1:1 motion is not observed between the crown advancer knob and the crown, retract and re-advance the crown into the lesion.  Repeat retracting and advancing the crown into the lesion until 1:1 movement is observed.  If the knob and the crown are not moving together, the crown may be driven into the lesion with too much force and may result in the crown springing forward on exiting the lesion.
• When moving the crown back and forth across the lesion, employ a series of intermittent treatment intervals and rest periods. 30-second rest periods are recommended after 30-second treatment intervals, with a maximum total treatment time of 8 minutes.
• Monitor the saline fluid level during the procedure. Normal saline and lubricant solution infusion is critical to OAD performance.
  • Do not kink or crush the saline tubing. Flow of saline will be reduced.
  • Check the saline tubing and connections for leaks during the procedure.
• Do not allow fluid to leak onto electrical connections of the OAS pump.

Applies to Diamondback 360™  Peripheral OAS – Exchangeable Series only:

• Do not detach the cartridge from the handle when the OAD is over the guide wire.  Kinking of the guide wire and/or not being able to reconnect the cartridge and the handle may occur.
• Do not track only the cartridge into the patient and then attempt to connect the handle.  Kinking of the guide wire and/or not being able to reconnect the cartridge and the handle may occur.
• Do not attempt to load a guide wire with a crossing profile >0.014” through the proximal end of the OAD.  Guide wire with a crossing profile >0.014” will not fit through the internal components of the OAD.
• Do not attempt to remove the cartridge from the handle when spinning.
   

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur and/or require intervention include, but are not limited to:

• Allergic reaction to medication/media/device components
• Amputation
• Anemia
• Aneurysm
• Bleeding complications which may require transfusion
• Cerebrovascular accident (CVA)
• Death
• Distal embolization
• Entry site complications
• Hemolysis
• Hypotension/hypertension
• Infection
• Myocardial infarction
• Pain
• Pseudoaneurysm
• Restenosis of treated segment that may require revascularization
• Renal insufficiency/failure
• Slow flow or no reflow phenomenon
• Thrombus
• Vessel closure, abrupt
• Vessel injury, including dissection and perforation that may require surgical repair
• Vessel spasm
• Vessel occlusion

Diamondback 360™ Peripheral OAS/Diamondback 360™ Peripheral OAS– Exchangeable Series are manufactured and distributed by Cardiovascular Systems, Inc. (CSI). CSI is a subsidiary of the Abbott Group of Companies.