CAPIO

Additional Manufacturer Narrative

BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECTED DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL 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 E1 AND G4: THIS COMPLAINT ORIGINATED IN THE UNITED STATES BUT WAS REPORTED TO BOSTON SCIENTIFIC VIA SURVEY SUBMISSION FROM THE UNITED KINGDOM. BLOCK H6: IMDRF IMPACT CODE A0501 CAPTURES THE REPORTABLE EVENT OF DART DETACHMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE DART DETACHED FROM THE SUTURE WHILE BEING LOADED ONTO THE CAPIO CARRIER, PRIOR TO DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH THE SAME CAPIO DEVICE AND WITH A NEW SUTURE. NO PATIENT COMPLICATIONS WERE REPORTED.