MAMBA™ Microcatheters Indications, Safety and Warnings

Intended Use/Indications For Use

The MAMBA and MAMBA Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature and can be used to exchange one guidewire for another.
The microcatheter is also intended to assist in the delivery of contrast media into the coronary vasculature.

Contradictions

This device should not be used in neurovasculature.

Warnings

• The microcatheter is to be used over a guidewire. Use of the microcatheter ahead of a guidewire may result in vessel trauma and/or device damage.
• Proximal marks should be used to gauge microcatheter position within the guide catheter to avoid unintentional advancement of microcatheter out of the guide catheter.
• Advancement of the microcatheter through a stented vessel can damage the microcatheter or stent damage and/or stent displacement.
• The microcatheter should be replaced with a new device if difficulty is encountered, when flushing or advancing over a guide wire. Failure to do so may result in microcatheter damage, guidewire lockup, or vessel trauma.
• Injection of contrast above 2068 kPa (300 psi) could lead to catheter rupture.

Precautions

• Flush and wipe device with sterile heparinized saline prior to use to ensure smooth movement of guidewire.
• The microcatheter should not be advanced ahead of the guidewire to avoid device damage.
• Always verify tip position before injecting contrast.
• Ensure removal of guidewire prior to contrast injection.
• Flush microcatheter after contrast injection to avoid guidewire lockup.
• Withdrawing device too quickly or with too much force could cause the device to stretch or the tip to separate.
• This product has not been tested for alcohol or drug delivery.

Adverse Events

• Allergic reaction (drug, contrast, device or other)
• Arrhythmia, including ventricular fibrillation or heart block
• Bleeding, hemorrhage or hematoma
• Cardiac tamponade/Pericardial effusion
• Cardiac arrest/Cardiogenic shock
• Cerebrovascular accident (stroke or transient ischemic attack)
• Death
• Embolism (air, tissue, device fragments, plaque)
• Hemodynamic compromise including vasovagal reaction
• Infection
• Myocardial ischemia or infarction
• Organ insufficiency/failure (heart, lung, kidney)
• Prolonged procedure which may include additional intervention(s)
• Radiation injury
• Thrombosis
• Vessel trauma (spasm, dissection, perforation, rupture, arteriovenous fistula, pseudoaneurysm)