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CrossBoss™ Catheter

Indications, Safety, and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE / INDICATIONS FOR USE

The CrossBoss Catheter is intended for use with a guidewire to access discrete regions of the coronary vasculature.

When used as part of the system consisting of the CrossBoss Catheter, Stingray LP Catheter, and Stingray Guidewire, the CrossBoss Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.

CONTRAINDICATIONS

  • Do not use with guidewire extension systems with a coupling profile larger than 0.014 in (0.36 mm) diameter (i.e. wave pattern coupling mechanism).


WARNINGS

  • To reduce the potential for vessel damage, the CrossBoss Catheter should only be used in vessels that are ≥1 mm in diameter.
  • Always use the included torque device during catheter advancement and manipulation especially during device rotation. Failure to use the included torque device may result in catheter failure and may result in patient injury.


PRECAUTIONS

  • The CrossBoss Catheter should be handled with care. Prior to use and during the procedure, inspect the packaging and catheter for bends, kinks, or other damage. Discontinue use if the catheter becomes damaged.
  • Do not use a syringe smaller than 5 cm³ (5 cc) when flushing the catheter.
  • Do not use an inflation or power assist device when flushing the catheter.
  • Use of device could result in sensitization or allergic reaction from exposure to nickel.


POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following:

  • Acute myocardial infarction
  • Artery spasm
  • Death
  • Embolism
  • Hemorrhage or hematoma
  • Infection
  • Neurological deficit
  • Prolonged procedure with possible additional intervention
  • Radiation injury
  • Stroke
  • Vessel trauma
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