PRESSUREWIRE¿

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PRESSUREWIRE X WIRELESS GUIDEWIRE CALIBRATION WAS SUCCESSFUL AND CONNECTED BUT SIGNAL DRIFT OCCURRED DURING EQUALIZATION AND COULD NOT BE COMPLETED. ATTEMPTS WERE MADE BUT THE SIGNAL DRIFT PERSISTED. TRANSMITTER LIGHT WAS STEADY GREEN. ANOTHER PRESSUREWIRE X WIRELESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE COREWIRE WAS BROKEN 3 CENTIMETERS (CM) PROXIMAL TO THE DISTAL TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAULTY PRESSURE 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, A DEFINITIVE CAUSE FOR THE REPORTED FAULTY PRESSURE REGISTRATION COULD NOT BE DETERMINED. THE RETURNED DEVICE WAS ABLE TO SUCCESSFULLY PERFORM ALL FUNCTIONAL TESTING WITHOUT ERROR, AND THERE WERE NO DAMAGES NOR ANOMALIES NOTED WHICH COULD BE ATTRIBUTED TO THE REPORTED FAULTY PRESSURE REGISTRATION. IN THIS CASE, IT IS POSSIBLE THAT THE GUIDEWIRE¿S LOCATION FOR EQUALIZATION WAS INADEQUATE, OR PROCEDURAL CONTAMINANTS OBSTRUCTED THE PRESSURE SENSOR, WHICH RESULTED IN THE REPORTED FAULTY PRESSURE REGISTRATION; HOWEVER, THESE CONDITIONS COULD NOT BE CONFIRMED. THE DISTAL TIP¿S BROKEN COREWIRE IS CONSISTENT WITH BEING DAMAGED DURING OR AFTER USE, OR EXCESSIVE TIP SHAPING, BUT IS UNRELATED TO THE REPORTED FAULTY PRESSURE REGISTRATION. 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.