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MAMBA™ Microcatheters Indications, Safety and Warnings

Indications, Safety, and Warnings


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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

MAMBA/MAMBA Flex Microcatheter

Intended Use/Indications For Use

The MAMBA™ and MAMBA™ Flex Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary vasculatures, 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 vasculatures.

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 device damage and/or vessel trauma.
  • Proximal marks should be used to gauge microcatheter position within the guide catheter to avoid over-advancement of the microcatheter.
  • Use of this product in narrow or tortuous vessels or over-torqueing the device in challenging anatomy increases risk of vessel trauma including perforation.
  • Advancement of the microcatheter under resistance may cause microcatheter and/or vessel damage.
  • Advancement of the microcatheter through a stented vessel can damage the microcatheter and/or cause stent displacement.
  • If a blocked/damaged lumen is encountered, e.g. when flushing with saline, infusing with contrast or advancing over a guidewire, the microcatheter should be replaced with a new device. Failure to do so may result in catheter rupture, guidewire lockup, or arterial injury.
  • It is recommended that this product only be used at a medical institution capable of promptly performing emergency open-heart surgery.

Precautions

  • Flush and wipe down device with sterilized saline prior to use to ensure smooth movement of guidewire.
  • Ensure all appropriate accessories are securely attached to the microcatheter prior to flushing.
  • The microcatheter should not be advanced ahead of the guidewire to avoid device damage.
  • Always verify tip position before injecting contrast.
  • Prior to advancing or withdrawing microcatheter, loosen hemostasis valve to avoid damage.
  • Do not over tighten Y-adapter/hemostasis valve to avoid microcatheter damage.
  • 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
  • Arrhythmia
  • Cardiac tamponade
  • Cardiogenic shock
  • Death
  • Embolism
  • Fever
  • Hematoma
  • Hemorrhage
  • Infection
  • Myocardial infarction/ischemia
  • Pericardial effusion
  • Radiation exposure
  • Renal failure
  • Stroke
  • Thrombosis
  • Vasospasm
  • Vessel trauma, including dissection, perforation, or arteriovenous fistula

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