ORCA?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION BUTTON STICKING. BLOCK H11: INVESTIGATION RESULT: WITH THE INFORMATION AVAILABLE, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF SUCTION BUTTON STICKING. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE REPORTED 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 EVENT. 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. 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 AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.