BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX PLUS

    MDR report key: 15958646 · Received December 12, 2022

    Report

    Report Number
    15958646
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 29, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO REMOVE STRING THAT CAME ATTACHED TO STENT, THE TOP J OF THE STENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387031 PERCUFLEX PLUS STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061752620 29973799

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA Female