BLOX

Additional Manufacturer Narrative

BLOCK E1: THE EVENT WAS REPORTED BY THE PHYSICIAN; HOWEVER, THE SPECIFIC DETAILS REMAIN UNKNOWN. THE HEALTHCARE FACILITY ADDRESS, PHONE AND FAX NUMBER ARE AS FOLLOWS: (B)(6). BLOCK H6: IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF BITE BLOX MATERIAL SEPARATION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PATIENT BIT THE BITEBLOX MOUTHPIECE WITH FORCE AND IT CRACKED. THE BITE FORCE THROUGH THE MOUTHPIECE CAUSED DAMAGE TO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITEBLOX. IT WAS REPORTED THAT THE PATIENT HAD A DOCUMENTED MENTAL HEALTH CONDITION AND WAS EXTREMELY AGITATED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.