RESCUE

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE: A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOX OF THE RESCUE RETRIEVAL FORCEPS WAS RECEIVED AND UNPACKED ON AN UNKNOWN DATE. DURING UNPACKING, THE SEAL OF THE PRODUCT POUCH WAS PEELED OFF AND THE BOX WAS FLATTENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVED DURING THIS EVENT.

Additional Manufacturer Narrative

REPORT NUMBER 3005099803-2024-01850 WAS SUBMITTED IN ERROR. BOSTON SCIENTIFIC CORPORATION DOES NOT HAVE A REGULATORY/CONTRACTUAL OBLIGATION TO REPORT FOR THE RESCUE DEVICE. THE MANUFACTURER, ANREI MEDICAL, HAS THE REGULATORY/CONTRACTUAL OBLIGATION TO REPORT. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. IMDRF DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOX OF THE RESCUE RETRIEVAL FORCEPS WAS RECEIVED AND UNPACKED ON AN UNKNOWN DATE. DURING UNPACKING, THE SEAL OF THE PRODUCT POUCH WAS PEELED OFF AND THE BOX WAS FLATTENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVED DURING THIS EVENT.