BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX URINARY DIVERSION STENT

    MDR report key: 22032475 · Received May 15, 2025

    Report

    Report Number
    2124215-2025-30752
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LJE
    UDI-DI
    08714729821151
    PMA / PMN Number
    K830803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE INVESTIGATION RESULTS OF CANCELLED / RESCHEDULED - POST SEDATION / SEDATION UNKNOWN. IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE INVESTIGATION RESULTS OF DEVICE - DIFFICULT TO ADVANCE. CORRECTION TO BLOCK D4 BASED ON ADDITIONAL INFORMATION RECEIVED ON MAY 27, 2025. BLOCK H11: THE PERCUFLEX URINARY DIVERSION STENT WAS RETURNED WITH THE POUCH AND THREE ACCESSORIES FOR ANALYSIS. THE REPORTED EVENT OF DEVICE - DIFFICULT TO ADVANCE WILL NOT BE CONFIRMED. DURING VISUAL AND MAGNIFICATION INSPECTION, AND WIRE INSERTION TEST, IT WAS FOUND THAT THE STENT SHAFT WAS DETACHED. IT IS POSSIBLE TO CONCLUDE THAT THIS ISSUE COULD BE CAUSED BY OPERATIONAL FACTORS. PROBABLY SOME MANIPULATION DURING THE PROCEDURE COULD HAVE CAUSED DETACH ON THE DEVICE. A SENSOR WIRE WAS INSERTED INTO STENT TO EVALUATE IF SOME RESISTANCE IS FELT INSIDE THE DEVICE, HOWEVER, NO RESISTANCE WAS FELT DURING THE ANALYSIS PERFORMED AND THE GUIDEWIRE WAS ABLE TO FULLY PASS THROUGH THE STENT, WHICH CANNOT CONFIRM THE REPORTED EVENT. THEREFORE, ALL COMPILED INFORMATION ON THIS INVESTIGATION DETERMINES THAT THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED / RESCHEDULED - POST SEDATION / SEDATION UNKNOWN. IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DEVICE - DIFFICULT TO ADVANCE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO CROSS. THE GUIDEWIRE COULD NOT BE INSERTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO CROSS. THE GUIDEWIRE COULD NOT BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183705 PERCUFLEX URINARY DIVERSION STENT CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC CORPORATION M0061603350 0035463047 08714729821151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention