SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A SHOCKWAVE L6 PERIPHERAL IVL CATHETER LABELED DEVICE POUCH (L6IVL080030, LOT 01A251024A) (MDR# 3015053858-2026-00066) WAS FOUND PACKAGED INSIDE A SHOCKWAVE M5+ PERIPHERAL IVL CATHETER CARTON (M5PIVL8060, LOT 82352170) (MDR# 3015053858-2026-00065). THE PHYSICIAN INTENDED TO USE A SHOCKWAVE M5+ 8.0X60 MM DEVICE DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC. THE SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER LABELED CARTON CONTAINED A SHOCKWAVE L6 8.0X30 MM DEVICE POUCH. THE INCORRECT SHOCKWAVE L6 DEVICE WAS NOTICED DURING THE PROCEDURE AT THE FIRST INFLATION AND WAS USED IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EVENTS, AND THE PATIENT WAS FINE. NO OTHER SHOCKWAVE DEVICES WERE USED DURING THE PROCEDURE. THE COMPANY REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. THE CUSTOMER DISCARDED EVERYTHING INCLUDING BOTH THE CARTON AND THE CATHETER.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED OF THE DEVICE OR PACKAGING. HOWEVER, IMAGES OF THE SHOCKWAVE L6 IVL CATHETER POUCH AND SHOCKWAVE M5+ CARTON WERE PROVIDED AND REVIEWED AS PART OF THE INVESTIGATION. THE REPORTED ISSUE WAS EVALUATED BY SHOCKWAVE BASED ON CUSTOMER-PROVIDED IMAGES, WHICH SHOWED THAT AN L6 CATHETER WAS PACKAGED INSIDE AN M5+ CARTON BOX. THE INVESTIGATION INCLUDED A REVIEW OF THE L6 MANUFACTURING LOT HISTORY RECORD, THE CONTRACT MANUFACTURER OF M5+ LOT HISTORY RECORD, AND CUSTOMER PRODUCT SHIPMENTS. MANUFACTURING FLOW, LOT TRACEABILITY, AND PROCESS CONTROLS WERE EVALUATED, WITH NO DEFICIENCIES IDENTIFIED IN THE MANUFACTURING OR PACKAGING PROCESSES FOR EITHER PRODUCT. THE INDIVIDUAL L6 DEVICE POUCH WAS CORRECTLY LABELED, AND THE M5+ CARTON WAS ALSO CORRECTLY LABELED. ADDITIONALLY, PRODUCT MOVEMENT TIMELINES WITHIN FACILITY FOR BOTH LOTS INDICATE THAT NEITHER WAS LIKELY TO HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE HAPPENED AT THE CUSTOMER SITE, SINCE SHIPMENT RECORDS SHOW THAT BOTH LOTS WERE SHIPPED TO THE CUSTOMER. INSTRUCTIONS FOR USE (IFU) FOR BOTH DEVICES SPECIFY THE SAME INDICATION FOR USE. THE IFU INSTRUCTS CUSTOMERS TO "CAREFULLY INSPECT ALL PACKAGING FOR DAMAGE OR DEFECTS PRIOR TO USE. DO NOT USE THE DEVICE IF ANY SIGN OF DAMAGE OR BREACH OF THE STERILE BARRIER IS OBSERVED AS THIS COULD LEAD TO MALFUNCTION OF THE DEVICE AND/OR INJURY TO THE PATIENT." EXPOSURE TO THE HAZARDOUS SITUATION FOR USE OF IMPROPER DEVICE SELECTION WHERE THE IVL BALLOON LENGTH AND CATHETER WORKING LENGTH WERE SHORTER THAN INTENDED RELATIVE TO THE TARGET LESION LENGTH AND ANATOMICAL LOCATION IN THE PERIPHERAL ARTERY CAN, IN EXTREMELY RARE CIRCUMSTANCES, CAN RESULT IN PROLONGED PROCEDURE. 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.