The Penumbra 5MAX™ and 4MAX™ Distal Delivery Catheters (DDC) are designed to simplify therapy delivery to the most distal, tortuous anatomy. The tapered inner shaft maximizes the effective flow lumen to facilitate exceptional angiographic roadmapping. These catheters are offered in three lengths, enabling 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 complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
Indication for Use
The Penumbra Distal Delivery Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
There are no known contraindications.
The Penumbra Distal Delivery Catheter should only be used by physicians who have received appropriate training in interventional techniques.
• The device is 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 vasculature location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return damaged devices and packaging to the manufacturer/distributor.
• Use prior to the “Use By” date.
• Use the Penumbra Distal Delivery Catheter in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the Penumbra Distal Delivery Catheter 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 an 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; false aneurysm formation; ischemia; air embolism; death; hematoma or hemorrhage at puncture site; neurological deficits including stroke; distal embolization; infection; emboli; intracranial hemorrhage; vessel spasm, thrombosis, dissection, or perforation.
5MAX DDC and 4MAX DDC
- 5MAX DDC 115 cm is compatible with neurovascular microcatheter, balloon and stent/flow diverter delivery systems
- 4MAX DDC has a distal profile, useful in smaller, more distal anatomy
- 5MAX DDC effective flow lumen—.062″ (1.57 mm)
- 4MAX DDC effective flow lumen—.053″ (1.35 mm)
- Distal radiopaque marker band
- Polished atraumatic tip
- Lengths include: 115 cm, 125 cm, and 130 cm
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