BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIO ASPIRATION CATHETER

    MDR report key: 23451659 · Received November 3, 2025

    Report

    Report Number
    2124215-2025-78865
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    April 11, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QEZ
    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 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).

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85706 RIO ASPIRATION CATHETER ASPIRATION THROMBECTOMY CATHETER QEZ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other