ORCA

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. DURING THE PROCEDURE, THE SUCTION BUTTON WAS PRESSED AND BECAME STUCK IN THE DEPRESSED POSITION. THE SUCTION BUTTON WAS UNABLE TO RETURN TO THE NEUTRAL POSITION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT VALVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. 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 E1: (B)(6). 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 MEDIA ANALYSIS: PRODUCT ANALYSIS COULD NOT BE PERFORMED, FOR THIS REASON AND DUE TO THE LACK OF EVIDENCE IS UNABLE TO CONFIRM THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED BECAUSE THE SHIP HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNAVAILABLE DOCUMENTATION INVESTIGATION CONCLUSION: BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE CUSTOMER THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE SUCTION BUTTON STICKING WAS DUE TO THE PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WAS RELATED TO A DEVICE MALFUNCTION. FOR THIS REASON, CAUSE NOT ESTABLISHED IS SELECTED AS THE MOST PROBABLE CAUSE FOR THIS EVENT. ON MAY 12, 2026, BOSTON SCIENTIFIC INITIATED A FIELD SAFETY CORRECTIVE ACTION (FSCA - BOSTON SCIENTIFIC REFERENCE: 97585870-FA) 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 MAY 12, 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.