BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 22081091 · Received May 23, 2025

    Report

    Report Number
    2124215-2025-33712
    Event Type
    Death
    Date Received
    May 23, 2025
    Date of Event
    January 1, 2024
    Report Date
    May 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO SAFE HARBOR DEIDENTIFICATION RULES WITH THE REGISTRY DATA OWNER (ACCF), DATA IN THE EVENT DATE AND DATE OF DEATH FIELDS ARE LIMITED TO THE YEAR ONLY. JANUARY 1 OF THE GIVEN YEAR WAS USED TO CAPTURE THIS. 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). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLLOWING EVENTS OCCURRED DEATH AT DISCHARGE DECEASED,ACUTE MYOCARDIAL INFARCTION CARDIAC ARREST 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262061 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death