BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELIVERY CATHETER SSPC3

    MDR report key: 23639324 · Received November 24, 2025

    Report

    Report Number
    2124215-2025-86219
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 24, 2025
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024670031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CATHETER WAS CANNULATED IN THE SUBCLAVIAN ARTERY WITH THE WIRE ASCENDING DOWN THE AORTA. THE PATIENT REPORTED TO HAVE EXPERIENCED BACK PAIN. FURTHER IMAGING WAS COMPLETED AND IDENTIFIED AN ANEURYSM PRESENT. THE ANEURYSM WAS SUCCESSFULLY TREATED AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313675 DELIVERY CATHETER SSPC3 CATHETER, PERCUTANEOUS DQY CENTERPOINT SYSTEMS 9183 CL14036 00810024670031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H