PRESSUREWIRE¿

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED MATERIAL SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS LIKELY THAT EITHER THE GUIDEWIRE TIP SHAPING TECHNIQUES EMPLOYED DURING PREPARATION FOR USE OR THE GUIDEWIRE WAS BEING ADVANCED OR WITHDRAWN EXCESSIVE FORCE, WHICH CAUSED THE REPORTED MATERIAL SEPARATION WHICH RESULTED IN UNEXPECTED MEDICAL INTERVENTION AND DEVICE EMBEDDED IN TISSUE OR PLAQUE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, A PRESSUREWIRE X WIRELESS DEVICE WAS USED IN THE LEFT MAIN ARTERY. REPORTEDLY, THE TIP OF THE PRESSUREWIRE BROKE OFF IN THE PATIENT¿S ARTERY. A STENT WAS ADVANCED TO SECURE THE SEPARATED TIP INTO THE VESSEL WALL. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS DUE TO THE INTERVENTION, AND THE PATIENT DID NOT SUSTAIN ANY HARM SUBSEQUENT TO THE TIP BEING EMBEDDED IN UNINTENDED HEALTHY TISSUE. THE PATIENT WAS DISCHARGED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.