BOBBY™ Indications, Safety, and Warnings

Warnings and Precaution

Warnings

• Verify the size of the vessel under fluoroscopy. Ensure that the balloon guide catheter is appropriate for the size of the vessel.

• Do not exceed the maximum recommended inflation volume as balloon rupture may occur.

• The balloon guide catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

• Viscosity and concentration of contrast may affect balloon inflation and deflation times.

• During preparation, do not deflate the balloon unless the distal tip is submerged in saline or contrast to prevent air from entering balloon.

• Attaching devices other than a syringe to the balloon inflation port may rupture the balloon.

• Do not inflate the balloon with air or any other gas while in the body.

• Improper preparation may introduce air into the system. The presence of air may inhibit proper fluoroscopic visualization.

• For working lumen, do not exceed 300 psi (2068 kPa) maximum recommended infusion pressure. Excess pressure may result in catheter rupture.

• When air-purging the balloon guide catheter, inject fluid slowly otherwise balloon rupture may occur.

• Do not advance the balloon guide catheter or guidewire against resistance. If resistance is felt, assess the source of resistance using fluoroscopic means.

• Always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.

• Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

• Do not exceed -28 inHg during aspiration.

• Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State or Local Health Authority in which the user and/or patient is established.

Precautions

• Immediately prior to use visually inspect all the sterile barrier systems, that are labeled as sterile. Do not use if breaches in sterile barrier system integrity are evident, such as a damaged pouch.

• After balloon preparation for use and prior to use, re-inflate to nominal volume and inspect for any irregularities or damage. Do not use if any inconsistencies are observed.

• Verify balloon guide catheter compatibility when using other ancillary devices commonly used in intravascular procedures.

• The balloon guide catheter has a lubricious surface and should be hydrated for at least 10 seconds prior to use. Once the balloon guide catheter is hydrated, do not allow it to dry.

• Exercise care in handling the balloon guide catheter to reduce the chance of accidental damage.

• Take precaution when navigating the balloon guide catheter in tortuous vasculature to avoid damage. Avoid advancement or withdrawal against resistance until the cause of resistance is determined.

• Presence of calcifications, irregularities or existing devices may damage the balloon guide catheter and potentially affect its insertion or removal.

• Excessive torque applied to the syringe might result in damage to the hub assembly.

• Exposure to angiographic and fluoroscopic X-ray presents potential risks of alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase.

• Exercise necessary precautions to limit x-ray doses to patients and operators by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Potential Complications

Potential complications include, but are not limited to: anaphylactic shock, blockage other than target vessel, cardiac arrest/Heart attack, inflammatory complication, myocardial embolism/Myocardial infarction, vessel or aneurysm perforation, vasospasm, hematoma/bleeding inside the brain, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection and/or fever, vessel dissection, thrombus formation, death, tissue necrosis, and toxic reaction.

Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure