BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 24905987 · Received April 16, 2026

    Report

    Report Number
    2134070-2026-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    UDI-DI
    10888551005920
    PMA / PMN Number
    K121158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: PC-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CATHETER AND WHEN THE STERILMED CATHETER PACKAGING WAS OPENED THERE WAS A WHITE RESIDUE ON THE CATHETER. THE CATHETER WAS REPLACED WITH ANOTHER AND THE CASE CONTINUED. THE STERILE PACKAGING WAS NOT OPENED UNTIL THE TIME OF THE PROCEDURE. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67308 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STERILMED, INC. 2245339 10888551005920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown