ANGIOMAT ILLUMENA

Description of Event or Problem

THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2020. INTENDED THERAPEUTIC DISEASE OR EFFECT: INTERVENTIONAL SURGERY FOR CARDIOVASCULAR DISEASE DEVICE MALFUNCTION: FAILURE OF PUSH ROD USAGE PROCESS: IN THE MORNING OF (B)(6) 2020, THE PATIENT WAS TREATED WITH TOSHIBA DSA SPECIAL HIGH-PRESSURE SYRINGE FOR INTERVENTIONAL SURGERY OF CARDIOVASCULAR DISEASE. THE FAILURE OF PUSH ROD APPEARED DURING THE SURGERY , THE DEVICE MALFUNCTION COULD NOT BE ELIMINATED AFTER RESTART, AND THE EQUIPMENT DIVISION WAS INFORMED IMMEDIATELY FOR REPAIR, THE HIGH PRESSURE SYRINGE COULD CONTINUE TO BE USED NORMALLY AFTER BEEN REPAIRED BY THE EQUIPMENT DEPARTMENT. THE HIGH PRESSURE SYRINGE MALFUNCTION RESULTED IN A UNSTABLE CONTRAST PRESSURE AND FLOW RATE DURING IMAGE ACQUISITION, WHICH AFFECTED THE SMOOTHLY PERFORMANCE OF SURGERY BUT HAD NOT SIGNIFICANT IMPACT ON THE PATIENT. THE DEVICE IS NOT LABELED WITH A MANUFACTURING DATE AND EXPIRATION DATE. CAUSE ANALYSIS OF THE EVENT: PRODUCT REASONS (INCLUDING INSTRUCTIONS FOR USE, ETC.) CAUSE ANALYSIS DESCRIPTION FOR THE EVENT: IT IS POSSIBLE INTERNAL FAULT OF THE DEVICE PRELIMINARY PROCESSING SITUATION: IMMEDIATELY NOTIFY THE EQUIPMENT DIVISION FOR REPAIR, THE HIGH PRESSURE SYRINGE COULD CONTINUE TO BE USED NORMALLY AFTER BEEN REPAIRED BY THE EQUIPMENT DEPARTMENT.