ISSUE: The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.
BACKGROUND: The Boston Scientific iCross and Atlantis A SR Pro2 coronary imaging catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is used on patients who are candidates for transluminal coronary interventional procedures.
