CAPIO

Additional Manufacturer Narrative

BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE EVENT DATE OF MARCH 14, 2026, WAS SELECTED AS A BEST ESTIMATE BASED ON THE REPORT THAT THE EVENT OCCURRED APPROXIMATELY ONE WEEK PRIOR TO THE PHYSICIAN'S EMAIL DATED (B)(6) 2026, WHICH WAS THEN FORWARDED TO BOSTON SCIENTIFIC ON (B)(6) 2026. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A0510 CAPTURES THE REPORTABLE EVENT OF CARRIER RETRACTION PROBLEM.

Description of Event or Problem

IT WAS REPORTED THAT A CAPIO DEVICE WAS USED IN A PROCEDURE. DURING THE PROCEDURE, THE CAPIO CARRIER WAS EXTREMELY STIFF AND NOT FULLY RETRACTING. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE.