BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 21599786 · Received March 13, 2025

    Report

    Report Number
    2124215-2025-15769
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    UDI-DI
    00685447004530
    PMA / PMN Number
    K073326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NRF TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE, SEVERAL ATTEMPTS TO PERFORM THE TRANSSEPTAL PUNCTURE WERE ATTEMPTED, WITHOUT SUCCESS. STEADY FORWARD PRESSURE AFTER THE ENERGY ATTEMPTS MOVED THE NRG NEEDLE FORWARD INTO THE LEFT ATRIUM (LA). NO PATIENT COMPLICATIONS WERE REPORTED. NO PROCEDURE OUTCOME WAS DISCLOSED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991642 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC NRG-E-HF-71-C1 0035128936 00685447004530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown