Description of Event or Problem · 1
IT WAS REPORTED THERE WAS UNSTABLE SPEED. A 1.25MM ROTAPRO,1.50MM ROTAPRO AND ROTAPRO CONSOLE WERE SELECTED FOR A PROCEDURE IN THE MID RIGHT CORONARY ARTERY WITH ADDITIONAL DIFFUSE CALCIUM PROXIMAL TO THE SECTION. THE PHYSICIAN TREATED THE MID RCA PORTION WITH A 1.25 ROTAPRO WITHOUT ISSUE. PLATFORMING SPEED WAS AT 160 RPM AND ABLATION WAS PERFORMED WITH A SPEED OF 170 RPM. NEXT, THE PHYSICIAN USED A 1.5 BURR TO TREAT THE MID LESION AND PROXIMAL SEGMENT. PLATFORMING SPEED WAS 170 RPM. DURING ABLATION, APPROXIMATELY TWO PASSES WERE MADE AT ABOUT 168 RPM IN THE BODY. ON THE THIRD PASS, THE SPEED STARTED AT ABOUT 168 RPM, THEN JUMPED TO 190, 200, AND 215 RPMS IN ABOUT 10 SECONDS. ALONG WITH THE SPEED CHANGE DISPLAYED ON THE CONSOLE, THE PHYSICIAN NOTICED THE SOUND OF THE ADVANCER WAS MUCH LOUDER. THE RUN WAS STOPPED. AN ADDITIONAL RUN WAS ATTEMPTED, BUT THE SAME THING OCCURRED WITH SPEED STARTING AT 168 RPMS AND JUMPING TO AROUND 200, 215 RPMS, ALONG WITH THE LOUDER NOISE. THIS OCCURRED POTENTIALLY ONE MORE TIME AND THE SPEED MAY HAVE INCREASED TO 220 OR 290 RPMS. THE BURR NEVER DROPPED IN SPEED, CONTINUOUS FLUSH WAS USED, AND THE CATHETER NEVER APPEARED TO BE LODGED OR STUCK. THE BURR WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.5 WOLVERINE AND A 4.0 SYNERGY STENT. THE PATIENT HAD NO APPARENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH NO OTHER PROBLEMS. ON A LATER DATE, THE CONSOLE WAS TESTED WITH A DEMO BURR AND THE ISSUE COULD NOT BE DUPLICATED.