SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION AND INSPECTED. THE REPORTED EVENT COULD NOT BE REPLICATED. ALL EMITTERS SHOWED NO SIGNS OF WEAR AND NO PHYSICAL DAMAGE WAS NOTED ON THE BALLOON SURFACE OR BALLOON TIP. A SHIPPING MANDREL AND INTRODUCER SHEATH WERE USED WITH THE CATHETER AND NO ANOMALIES WERE NOTED. THE CAUSE OF THE HEMATOMA AND INABILITY TO NAVIGATE UP AND OVER THE PATIENT'S SEVERELY CALCIFIED ILIAC ARTERIES COULD NOT BE DEFINITIVELY DETERMINED. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

Description of Event or Problem

IT WAS REPORTED THAT A SHOCKWAVE E8 PERIPHERAL IVL CATHETER WAS USED TO TREAT A LESION IN THE TIBIAL/PERONEAL ARTERIES. ACCESS WAS GAINED VIA THE CONTRALATERAL FEMORAL ARTERY USING A 45CM DESTINATION 6F SHEATH. DUE TO THE PATIENT'S ANATOMY, THE PHYSICIAN WAS UNABLE TO NAVIGATE UP AND OVER THEIR SEVERELY CALCIFIED ILIAC ARTERIES AND SUBSEQUENT ATTEMPTS TO EXCHANGE TO A LONGER SHEATH WERE UNSUCCESSFUL. THE PATIENT DEVELOPED A HEMATOMA AT THE GROIN SITE. NO RESISTANCE WAS NOTED WHILE TRACKING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE SHEATH. THE PATIENT'S SEVERELY CALCIFIED ANATOMY WITH A SUBTOTAL OCCLUSION OF THE DISTAL POPLITEAL PROVIDED FOR POOR SUPPORT. PRESSURE WAS HELD IN AN ATTEMPT TO CONTROL THE HEMATOMA, BUT A CUTDOWN WAS ULTIMATELY REQUIRED. THE EVENT WAS RESOLVED AND THE PATIENT WAS LATER DISCHARGED.