Precautions; Adverse Events - Boston Scientific Rotablator Gebrauchsanweisung

• Never operate the Rotablator™ advancer without saline infusion. Flowing
saline is essential for cooling and lubricating the working parts of the
advancer. Operation of the advancer without proper saline infusion may result
in permanent damage to the advancer.
• Never operate the Rotablator advancer in Dynaglide™ mode or operate the
guidewire brake defeat button unless you have a firm grip on the guidewire
using the wireClip™ torquer. The wireClip torquer may be held with the
fingers or inserted completely into the docking port after the brake button
is depressed. Defeating the brake, or operating the Rotablator advancer in
Dynaglide mode, without securing the guidewire may result in rotation and
entanglement of the guidewire.
• During setup of the Rotablator System never grip or pull on the flexible shaft.
• The burr at the distal tip of the RotaLink™ catheter is capable of rotating
at very high speeds. Do NOT allow parts of the body or clothing to come in
contact with the burr. Contact may result in physical injury or entanglement.
• Never advance the rotating burr to the point of contact with the guidewire spring
tip. Such contact could result in distal detachment and embolization of the tip.
• If the Rotablator advancer stops and the red STALL light on the console
illuminates, retract the burr and immediately discontinue treatment. Check the
advancer for proper connection to the console. If the connections are correct,
use fluoroscopy to analyze the situation. Never force the system when
rotational or translational resistance occurs, as vessel perforation may occur.
• Never advance the rotating burr by advancing the sheath. Guidewire buckling
may occur and perforation or vascular trauma may result. Always advance
the rotating burr by using the advancer knob.
• If resistance is encountered, retract the burr and stop treatment immediately.
Use fluoroscopy to analyze the situation. Never force the Rotablator advancer
when rotational or translational resistance occurs, as vessel perforation,
vessel trauma or embolism due to burr detachment or fractured wire may
occur and in rare instances may result in surgical intervention and death.
• The use of Rotablator for in-stent restenosis might lead to damage of stent
components and/or Rotablator System, which may lead to patient injury.
• A lways keep the burr advancing or retracting while it is rotating. Maintaining
the burr in one location while it is rotating may lead to excessive tissue
removal or damage to the Rotablator System or entrapment of the Rotablator
System. It is best to advance and retreat the burr no more than 3 cm at a time
in a smooth pecking motion, being careful to engage the lesion only minimally
when resistance is met. Short individual runs of less than 30 seconds are
recommended with total rotational procedure time not to exceed five minutes.

PRECAUTIONS

• Treating certain types and/or locations of lesions or patients with certain
conditions is inherently riskier, regardless of the therapeutic device being
used. For many of these applications, relatively few cases have been carried
out using the Rotablator System. Physicians should be aware of the higher
risk when treating such patients and the lack of scientific evidence for
treatment in the following applications:
1. Patients who are not candidates for coronary artery bypass surgery;
2. Patients with severe, diffuse three-vessel disease (multiple diseased
vessels should be treated in separate sessions);
3. Patients with unprotected left main coronary artery disease;
4. Patients with ejection fraction less than 30%;
5. Lesions longer than 25 mm;
6. Angulated (≥ 45°) lesions.
• Percutaneous rotational angioplasty with the Rotablator System should
only be carried out at hospitals where emergency bypass surgery can be
immediately performed in the event of a potentially injurious or lifethreatening
complication.
• Appropriate drug therapy including (but not limited to) anticoagulant and
vasodilator therapy must be provided to the patient during all phases of
patient care.
• A temporary pacing lead may be necessary and is particularly recommended
during the treatment of lesions in the right coronary and dominant circumflex
arteries to resolve electrophysiological aberrations which may occur.
• When the Rotablator guidewires and/or catheters are in the body, they should
only be manipulated while they are under fluoroscopic observation with
radiographic equipment that provides high resolution images.
• There has been limited experience with the brachial approach.
• Use only normal saline as the infusate. Never inject contrast agent, or any other
substance that is not approved as part of the Rotablator System, into the infusion
port or saline infusion bag as this may cause permanent damage to the advancer.

ADVERSE EVENTS

Potential adverse reactions which may result from the use of this device include
but are not limited to:
• Angina or unstable angina
• Arrhythmias
• Bailout stenting
• Cardiac perforation
• Cardiac tamponade
• Conduction block
• Coronary artery spasm
• Death
• Drug reaction, allergic reaction to contrast media
• Embolism (coronary, cerebral, peripheral)
• Hemorrhage or hematoma
• Infection, local infection, systemic infection
• Myocardial ischemia
• Myocardial infarction (Q-wave and non Q-Wave)
• Pericardial effusion
• Pulmonary edema/cardiogenic shock
• Slow flow, no flow, abrupt vessel closure
• Stroke
• Vascular thrombus
• Vessel trauma (dissection, perforation, rupture or injury)
There may also be complications associated with distortion, kinks, and fracture of
the guidewire and physical deterioration or malfunction of the device, which can
lead to patient injury or death.
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