BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 23513484 · Received November 10, 2025

    Report

    Report Number
    2124215-2025-81200
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    August 19, 2025
    Report Date
    June 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    UDI-DI
    08714729257318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE G041115 CAPTURES THE REPORTABLE INVESTIGATION RESULTS OF SLEEVE DETACHED. BLOCK H11: THE RETURNED SENSOR WIRE WAS ANALYZED, AND DURING THE INSPECTION, IT WAS POSSIBLE TO OBSERVE THAT THE GUIDEWIRE WAS KINKED, THE SLEEVE WAS DETACHED, AND THE PTFE WAS PEELED AT THE DISTAL SECTION OF THE DEVICE. BASED ON THE INVESTIGATION, THE SLEEVE WAS DETACHED FROM THE WIRE, AND THE GUIDEWIRE WAS KINKED. THE EXCESS OF FORCE APPLIED FOR REMOVED THE WIRE PROBABLY CAUSED THE DETACH OF THE SLEEVE. BASED ON THE ANALYSIS RESULTS REGARDING THE OBSERVED DETACHED SLEEVE, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION, THE PHYSICIAN COMMENTED THAT THE SENSOR GUIDEWIRE WAS NOT SLIDING SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615346 SENSOR STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION M0066703091 0033871108 08714729257318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown