SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE BALLOON DETACHMENT COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. 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

A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. FOLLOWING SUCCESSFUL IVL TREATMENT AND DURING DEVICE REMOVAL AT THE PROXIMAL ANTERIOR TIBIAL (AT) ARTERY, A PORTION OF THE BALLOON DETACHED FROM THE CATHETER. APPROXIMATELY 2 CM OF THE BALLOON SEPARATED AND COULD NOT BE RETRIEVED, AND WAS SUBSEQUENTLY STENTED AGAINST THE VESSEL WALL. THE BALLOON WAS REPORTED TO BE FULLY DEFLATED PRIOR TO REMOVAL, WITH NO BALLOON RUPTURE OR PRESSURE LOSS OBSERVED. NO EXCESSIVE FORCE WAS REPORTEDLY USED DURING DEVICE MANIPULATION OR REMOVAL. NO PATIENT HARM WAS REPORTED.