ORCA

Additional Manufacturer Narrative

BLOCK B3 (DATE OF EVENT): DATE OF EVENT WAS APPROXIMATED TO 06/01/2026 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE UNIQUE IDENTIFIER (UDI) #, MANUFACTURE DATE, AND EXPIRATION DATE ARE UNKNOWN. 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 PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE SUCTION BUTTON WAS STUCK IN SCOPE AND SUBSEQUENTLY FELL APART. 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.