Description of Event or Problem · 0
THE DUALPRO IVUS+NIRS IMAGING CATHETER (MODEL NUMBER: TVC-C195-42) IS A SINGLE-USE CORONARY CATHETER INTENDED FOR USE WITH THE MAKOTO IVUS+NIRS IMAGING SYSTEM. PRIOR TO CATHETER INSERTION, THE PHYSICIAN PRE-DILATED A HEAVILY CALCIFIED SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). ALTHOUGH RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, THE CATHETER SUCCESSFULLY CROSSED THE LESION. AN AUTOMATED PULLBACK WAS THEN INITIATED TO PERFORM AN IVUS RUN OF THE RCA. AT THE START OF THE PULLBACK, THE PHYSICIAN NOTED AN ABNORMAL WHIRRING SOUND, PROMPTING AN IMMEDIATE HALT TO THE PROCEDURE. THE CATHETER HAD BECOME LODGED IN THE CALCIFIED SEGMENT AND COULD NOT BE WITHDRAWN. TO DISLODGE IT, THE PHYSICIAN ATTEMPTED TO TORQUE THE GUIDE CATHETER, WHICH RESULTED IN A DISSECTION OF THE RCA. DURING THIS MANEUVER, THE DISTAL PORTION OF THE DUALPRO CATHETER SHEATH DETACHED AND REMAINED WITHIN THE VESSEL. UPON REMOVAL OF THE REMAINING SYSTEM COMPONENTS, APPROXIMATELY 6-8 MM OF THE CATHETER SHEATH WAS FOUND TO BE RETAINED IN THE ARTERY. THE PHYSICIAN ATTEMPTED RETRIEVAL BY WITHDRAWING THE GUIDE CATHETER, IVUS CATHETER, AND GUIDEWIRE AS A UNIT, BUT THE EFFORT WAS UNSUCCESSFUL. DUE TO THE FRAGMENT'S LOCATION, THE PHYSICIAN DETERMINED THAT SNARING WAS UNLIKELY TO BE EFFECTIVE. AS A RESULT, THE DECISION WAS MADE TO STENT THE FRAGMENT IN PLACE AGAINST THE VESSEL WALL. THE FRAGMENT WAS SUCCESSFULLY SECURED IN THIS MANNER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT AND IS RECOVERING WELL FOLLOWING THE PROCEDURE.