USER FACILITY DECLINED TO PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION. DEVICE EVALUATION COMPLETED 28FEB2019: ATTEMPTED TO CALIBRATE CATHETER AND RECEIVED FAULT CODE DURING CALIBRATION. DISTAL TIP OF CATHETER WAS EVALUATED UNDER MICROSCOPE AND IDENTIFIED 5 DEAD LASER FIBERS. PROXIMAL COUPLER FIBER PACK WAS EVALUATED AND IDENTIFIED 5 DEAD FIBERS. IT WAS OBSERVED THAT THE LASER BEAM TO THE CAPILLARY ALIGNMENT WAS SHIFTED SLIGHTLY HIGH. NO DAMAGE TO THE TAIL FUSE. EVALUATION OF THE WORKING LENGTH IDENTIFIED A BROKEN FIBER JUST DISTAL OF THE PORT AND A HOLE IN THE JACKET 5MM DISTAL TO THE INNER LUMEN EXIT OF THE PORT.
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Patient 1
A PHILIPS REPRESENTATIVE REPORTED THAT A CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT AN ACUTE CORONARY SYNDROME (ACS) EVENT. PATIENT HAD SEVERE ISR AND THE LASER FAILED WHEN TRYING TO OPERATE AT HIGHER LASER ENERGY. PHYSICIAN USED ANOTHER CATHETER TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. 28FEB2019: DURING DEVICE EVALUATION, IT WAS DETECTED THAT THERE WAS A BREACH IN THE CATHETER JACKET. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.