SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA)/POPLITEAL ARTERY. THE IVL BALLOON RUPTURED FOLLOWED BY PARTIAL DETACHMENT WHILE IT WAS BEING PULLED OUT OF A 5F SHORT SHEATH; THE M5+ IVL IFU SPECIFIES THE USE OF A 6F SHEATH. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR A SURGICAL CUT-DOWN PROCEDURE TO REMOVE THE DETACHED PORTION OF THE IVL BALLOON. NO PATIENT HARM WAS REPORTED. THE PATIENT WAS DISCHARGED, AND NO OTHER ISSUES REPORTED.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RECEIVED AT SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION HAS NOT BEEN PERFORMED. EVALUATION OF THE SUBJECT DEVICE IS ANTICIPATED BUT HAS NOT YET BEGUN. AFTER THE DEVICE IS RECEIVED AND INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.