ORCA

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF THE SUCTION BUTTON PHYSICAL RESISTANCE / STICKING.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A PROCEDURE IN THE STOMACH PERFORMED ON (B)(6) 2026. DURING THE PREPARATION, THE ORCA SUCTION BUTTON WAS INSTALLED; HOWEVER, A PROBLEM OCCURRED WHERE THE BUTTON FAILED TO RETURN AFTER BEING PRESSED. RESISTANCE WAS ALSO ENCOUNTERED DURING ATTACHMENT AND REMOVAL OF THE BUTTON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.