ORCAPOD?

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE, FOR BIOPSY. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED AN AIR/WATER BUTTON LEAK, A FLOW ISSUE, AND A SUCTION PROBLEM. DESPITE THESE ISSUES, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS DELAYED AS A RESULT OF THESE ISSUES. 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.

Additional Manufacturer Narrative

BLOCK D2B: SUBSEQUENT PRODUCT CODE OCX.B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 06/01/2026 AS NO EVENT DATE WAS REPORTED.BLOCK D4, H4:DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.BLOCK H6:IMDRF DEVICE CODE A050401CAPTURES THE REPORTABLE EVENT OF AIR WATER BUTTON LEAKING.