BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX? PLUS

    MDR report key: 21599458 · Received March 13, 2025

    Report

    Report Number
    2124215-2025-15107
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    January 22, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. BLOCKS B5, D4, D6A, D6B, E1, AND E3, HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MARCH 17, 2025.

    Additional Manufacturer Narrative · 0

    DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2025. A PLANNED STENT REMOVAL PROCEDURE WAS THEN PERFORMED ON (B)(6) 2025, TO EXPLANT THE STENT. DURING THIS PROCEDURE, IT WAS FOUND THAT THE STENT MIGRATED INTO THE URETER. THE STENT WAS REMOVED UNDER URETEROSCOPY AND COMPLETED THE PROCEDURE. THERE WAS NO NEW STENT IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS IMPLANTED INTO THE PATIENT. A PLANNED STENT REMOVAL PROCEDURE WAS THEN PERFORMED TO EXPLANT THE STENT. DURING THIS PROCEDURE, IT WAS FOUND THAT THE STENT MIGRATED INTO THE URETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823163 PERCUFLEX? PLUS CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION M0061752630 0032366840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown