AUTOCAP RX

Additional Manufacturer Narrative

BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A050401 CAPTURES THE REPORTABLE EVENT OF THE BIOPSY CAP LEAK.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP WAS USED FOR DUODENUM DURING AN ERCP PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, AIR AND WATER WERE OBSERVED LEAKING FROM THE BIOPSY BUNG CAP. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.