ORCA

Additional Manufacturer Narrative

BLOCK E1: THE HEALTHCARE FACILITY CITY ADDRESS IS (B)(6). BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION VALVE STICKING.

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. DURING THE PROCEDURE, THE ORCA DEVICE WAS ATTACHED TO THE ENDOSCOPE. WHEN THE SUCTION BUTTON WAS PRESSED, IT BECAME STUCK AND DID NOT RETURN TO ITS ORIGINAL POSITION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.