OPTICROSS™ 35
15 MHz Peripheral Imaging Catheter + MDU5 PLUS™ Sterile Bag

Indications, Safety, and Warnings


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.

OPTICROSS™ 35 PERIPHERAL IMAGING CATHETER AND MDU5 PLUS™ STERILE BAG

INTENDED USE/INDICATIONS FOR USE

OptiCross 35 15 MHz Catheter: This catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

MDU5 PLUS Sterile Bag:  The MDU5 PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

 

CONTRAINDICATIONS

OptiCross 35 15 MHz Catheter: This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization. This device is not to be used in the coronary arteries. MDU5 PLUS Sterile Bag: None known.

 

WARNINGS

  • Do not pinch, crush, kink or sharply bend the catheter at any time. This can cause poor catheter performance, vessel injury or patient complications. An insertion angle greater than 45° is considered excessive and can lead to device kinking which can cause difficult advancing/retracting the telescope shaft and poor image quality.
  • DO NOT advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.
  • When advancing or retracting the catheter through a stented vessel, the catheter tip may interact with the stent, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • If resistance is met upon withdrawal of the catheter, assess the cause of resistance using fluoroscopy, and if necessary, remove the entire system as a unit.
  • Do not advance the catheter along a guidewire that may be passing between one or more stent struts. This could result in entrapment of catheter/guidewire, catheter tip separation and/or stent dislocation. Use caution when introducing or removing the catheter from a stented vessel.

 

PRECAUTIONS

Do not advance the imaging core if resistance is encountered

MDU5 PLUS Sterile Bag: None known

 

ADVERSE EVENTS

The risks and discomforts involved in vascular imaging include those associated with all catheterization procedures. These risks or discomforts may occur at any time with varying frequency or severity. Additionally, these complications may necessitate additional medical treatment including surgical intervention and, in rare instances, result in death. Complications may include:

  • Allergic reaction (device, contrast or other)
  • Arrhythmia
  • Device entrapment requiring surgical intervention
  • Embolism (air, foreign body, tissue or thrombus)
  • Hemorrhage/Hematoma
  • Hepatic dysfunction
  • Hypotension/hypertension
  • Infection/sepsis
  • Ischemia
  • Renal insufficiency/failure
  • Stroke/cerebrovascular accident/transient ischemic attack
  • Thrombosis/thrombus
  • Vasospasm
  • Vessel injury (including perforation, trauma, rupture, dissection, and pseudoaneurysm)
  • Vessel occluion

MDU5 PLUS Sterile Bag: None known. 

9255184

 

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