BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELIVERY CATHETER SSPC2

    MDR report key: 24144459 · Received January 22, 2026

    Report

    Report Number
    2124215-2026-03985
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 22, 2026
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024671823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CATHETER WAS SEVERELY BENT IN THE MIDDLE PART RESULTING IN PLACEMENT DIFFICULTY. A NEW LEAD AND CATHETER WERE USED TO PROCEED WITH THE IMPLANT. THIS CATHETER WAS DISCARDED DUE TO CONTAMINATION AND WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203862 DELIVERY CATHETER SSPC2 CATHETER, PERCUTANEOUS DQY CENTERPOINT SYSTEMS 9182 00810024671823

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male