The Penumbra 5MAX™ and 4MAX™ Distal Delivery Catheters (DDC) are designed to simplify therapy delivery to the most distal, tortuous anatomy. Additionally, the unique tapered inner shaft maximizes the effective flow lumen to facilitate exceptional angiographic roadmapping. DDC is offered in three lengths to enable a wide variety of device compatibility.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for Penumbra Delivery Microcatheters for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.
Indication For Use
The Penumbra Delivery Microcatheters are indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
There are no known contraindications.
• The Penumbra Delivery Microcatheters should only be used by physicians who have received appropriate training in interventional techniques.
• The devices are intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer / distributor.
• Use prior to the “Use By” date.
• Use the Penumbra Delivery Microcatheters in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the Penumbra Delivery Microcatheters against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torquing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
• Acute occlusion
• Hematoma or hemorrhage at access site
• Intracranial hemorrhage
• Infection (at access site)
• Distal embolization
• Ischemia (cardiac and/or cerebral)
• Embolus (air, foreign body, thrombus, plaque)
• Aneurysm perforation
• False aneurysm formation
• Neurological deficits including stroke
• Vessel spasm, thrombosis, dissection, perforation or rupture
• Air embolism
5MAX™ DDC and 4MAX™ DDC
- 5MAX DDC 115 is compatible with neurovascular microcatheter, balloon and stent/flow diverter delivery systems
- 4MAX DDC has a distal profile, useful in smaller, more distal anatomy
- Built with MAX™ Tracking Technology
- 5MAX DDC effective flow lumen—.062″
- 4MAX DDC effective flow lumen—.053″
- Distal radiopaque marker band
- Polished atraumatic tip
- Lengths include: 115 cm, 125 cm, and 130 cm
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