BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX? PLUS

    MDR report key: 21795281 · Received April 8, 2025

    Report

    Report Number
    2124215-2025-20529
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE STENT CURLED INWARDS IN AN ACCORDION SHAPE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754318 PERCUFLEX? PLUS CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION M0061752540 0033990540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown