PRESSUREWIRE¿

Description of Event or Problem

REPORTEDLY, TWO PWX DEVICES (50610G1) WERE CALIBRATED SUCCESSFULLY. HOWEVER, THE SIGNAL WAS LOST, AND THE TRANSMITTER BEGAN FLASHING YELLOW WHEN THE DEVICES WERE INSERTED INTO THE PATIENT'S ANATOMY. THEREFORE, THE DEVICES WERE REMOVED AND ANOTHER PWX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING THE PRODUCT RETURN INVESTIGATION FOR (B)(4), THE DISTAL TUBE WAS OBSERVED TO BE TORN AND EXPOSING THE MICRO CABLES AT THE NOTED KINK.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION PROBLEM WAS NOT ABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 (FLASHING YELLOW LIGHT) APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS, BENDS, TWISTS, AND A CUT/TEAR TO THE DISTAL TUBE MATERIAL OF THE GUIDEWIRE, WHICH WILL CAUSE THE REPORTED COMMUNICATION PROBLEM. IN THIS CASE, IT IS LIKELY THAT THE USE/HANDLING TECHNIQUE EMPLOYED DURING DEVICE INSERTION CAUSED THE OBSERVED GUIDEWIRE DAMAGE WHICH RESULTED IN THE REPORTED FLASHING YELLOW LIGHT. 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.