BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC EMERGE

    MDR report key: 20614297 · Received November 5, 2024

    Report

    Report Number
    2124215-2024-68507
    Event Type
    Death
    Date Received
    November 5, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    K141236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    AGENT PAS REGISTRY IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTRAPROCEDURE/POST PROCEDURE EVENTS OF CARDIOGENIC SHOCK AND NEW REQUIREMENT FOR DIALYSIS. THE PATIENT DIED DURING THE PROCEDURE. CAUSE OF DEATH WAS "OTHER CARDIOVASCULAR REASON". THE FOLLOWING EVENT, BASED ON DATA FROM THE AGENT PAS 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 AGENT PAS 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 AGENT PAS REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992102 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Death