BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX PLUS

    MDR report key: 20351420 · Received October 2, 2024

    Report

    Report Number
    2124215-2024-60992
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729041184
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD HIS URETERAL STENT REMOVED ONE MONTH AFTER SURGERY FOR BILATERAL KIDNEY STONES. DURING SURGERY, IT WAS FOUND THAT THE URETERAL STENT WAS FULL OF STONES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007276 PERCUFLEX PLUS CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION M0061752630 0031741478 08714729041184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention