Orca?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION BUTTON STICKING. BLOCK H11: AT THIS TIME THE DEVICE IS CURRENTLY UNDERGOING TECHNICAL ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE RESULTS ARE AVAILABLE. ON MAY 12, 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.