BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIA FIRM

    MDR report key: 20882215 · Received December 9, 2024

    Report

    Report Number
    2124215-2024-76914
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K190603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL, INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS FOUND PLEATED, INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503151 TRIA FIRM STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M006190212090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown