PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION PROBLEM WAS NOT ABLE TO BE CONFIRMED. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED COMMUNICATION PROBLEM APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS, BENDS, AND DAMAGE TO THE SENSOR JACKET AND MICROCABLES, WHICH CAUSED THE REPORTED FLASHING GREEN/YELLOW LIGHTS. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING TECHNIQUES EMPLOYED. 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 PREPARATION, THE 2 PRESSUREWIRE X, WIRELESS DEVICES FAILED TO CONNECT TO THE SYSTEM AND CALIBRATION WAS NOT PERFORMED. THE TRANSMITTER LIGHT WAS FLASHING YELLOW AND GREEN. THEREFORE, THE DEVICES WERE NOT USED IN THE PATIENT AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE DISTAL TUBE AND MICRO CABLES WERE BROKEN AT THE PROXIMAL END OF THE SENSOR JACKET AND HELD IN PLACE BY THE CORE WIRE.