BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, PERCUTANEOUS

    MDR report key: 24062896 · Received January 13, 2026

    Report

    Report Number
    2124215-2026-02306
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 17, 2025
    Report Date
    May 23, 2026
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024670444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL CORRECTION REPORT WAS CREATED TO CAPTURE THIS EVENT AS NON BOSTON SCIENTIFIC PRODUCT, THUS THIS OBSERVATION NO LONGER MEETS THE DEFINITION OF COMPLAINT CRITERIA. AMENDING MDR DECISION TO MDR=NO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION, WHEN TORQUE WAS APPLIED TO THE GUIDING CATHETER (GC), FORCE WAS EXERTED ON THE JUNCTION BETWEEN THE HUB AND THE GC, CAUSING THE CATHETER TO KINK. A NEW CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION, WHEN TORQUE WAS APPLIED TO THE GUIDING CATHETER (GC), FORCE WAS EXERTED ON THE JUNCTION BETWEEN THE HUB AND THE GC, CAUSING THE CATHETER TO KINK. A NEW CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502161 CATHETER, PERCUTANEOUS DQY CENTERPOINT SYSTEMS 9287 CL14058 00810024670444

    Patients

    Seq Age Sex Outcome Treatment
    1