RIO ASPIRATION CATHETER

Additional Manufacturer Narrative

DUE TO SAFE HARBOR DEIDENTIFICATION RULES WITH THE REGISTRY DATA OWNER (ACCF), DATA IN THE EVENT DATE FIELD IS LIMITED TO THE YEAR ONLY. JANUARY 1 OF THE GIVEN YEAR WAS USED TO CAPTURE THIS. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

Description of Event or Problem

AGENT PAS REGISTRY IT WAS REPORTED THAT HEART FAILURE OCCURRED. THE FOLLOWING EVENT, BASED ON DATA FROM THE CATHPCI REGISTRY, IS BEING REPORTED AS A POSSIBLE DUPLICATE OF AN EVENT THAT WAS ALREADY KNOWN TO BSC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BSC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE CATHPCI REGISTRY DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. INITIAL REPORTER IS NOT PROVIDED DUE TO THE TERMS OF THE CATHPCI REGISTRY.

Description of Event or Problem

IT WAS REPORTED THAT HEART FAILURE OCCURRED. THE FOLLOWING EVENT, BASED ON DATA FROM THE CATHPCI REGISTRY, IS BEING REPORTED AS A POSSIBLE DUPLICATE OF AN EVENT THAT WAS ALREADY KNOWN TO BSC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BSC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE CATHPCI REGISTRY DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. INITIAL REPORTER IS NOT PROVIDED DUE TO THE TERMS OF THE CATHPCI REGISTRY.

Additional Manufacturer Narrative

DUE TO SAFE HARBOR DEIDENTIFICATION RULES WITH THE REGISTRY DATA OWNER (ACCF), DATA IN THE EVENT DATE FIELD IS LIMITED TO THE YEAR ONLY. JANUARY 1 OF THE GIVEN YEAR WAS USED TO CAPTURE THIS. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU).