Device Dossier

MAMBA™ Flex Microcatheter - Intravascular microflow catheter

Device Dossier for MAMBA™ Flex Microcatheter - Intravascular microflow catheter (Intravascular microflow catheter, Class III, sponsor Boston Scientific).…

Intended purpose

The 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.

Functional description

The device is designed to provide a platform for exchange guidewires without losing position within the vasculature. Marks on the proximal portion of the catheter shaft and a radiopaque marker at the distal tip facilitate placement of the device. The shaft consists of a coil which allows the device to be torqued and a Hydrophilic Coating to assist in advancement. The proximal end has a luer hub for flushing/injecting through the inner lumen. The luer hub also allows for Insertion of a guidewire

TGA Public Summary