ORCA?

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2026. THE SUCTION BUTTONS WERE STICKING BOTH BEFORE AND DURING THE PROCEDURE. EVEN AFTER SOAKING THE BUTTONS IN WATER, APPLYING LUBRICANT, AND REDUCING THE SUCTION LEVEL, THE ISSUE CONTINUED TO OCCUR INTERMITTENTLY. SOME BUTTONS BECAME STUCK ON THE FIRST PRESS, WHILE OTHERS FUNCTIONED NORMALLY THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION VALVE STICKING. WITH THE AVAILABLE INFORMATION, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. WITHOUT A PRODUCT RETURNED, NO PRODUCT ANALYSIS COULD BE CONDUCTED. THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE FOR THE EVENT CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENTS. SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENTS, ""CAUSE NOT ESTABLISHED"" IS SELECTED AS THE MOST PROBABLE CAUSE FOR THE COMPLAINT. BLOCK H7, H9: ON (B)(6) 2026, BOSTON SCIENTIFIC INITIATED A FIELD SAFETY CORRECTIVE ACTION (FSCA - BOSTON SCIENTIFIC REFERENCE: (B)(4)) THAT INCLUDED THE REMOVAL OF ORCA? SINGLE USE AIR/WATER AND SUCTION VALVES ASSOCIATED WITH BATCH NUMBER 38400303 DUE TO INCREASED REPORTS OF SUCTION BUTTON STICKING ISSUES. A COMMUNICATION WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON (B)(6) 2026, WITH INSTRUCTIONS TO IMMEDIATELY STOP FURTHER USE OR DISTRIBUTION OF ORCA? SINGLE USE AIR/WATER AND SUCTION VALVES ASSOCIATED WITH BATCH NUMBER 38400303, REMOVE THE DEVICES FROM INVENTORY, AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. BOSTON SCIENTIFIC WILL CONTINUE TO CLOSELY MONITOR AND TREND SIMILAR EVENTS AND ASSOCIATED RISKS, AS OUTLINED IN OUR QUALITY SYSTEMS PROCESS.