BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11601979 · Received April 1, 2021

    Report

    Report Number
    9710452-2021-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 1, 2021
    Product Code
    DXF
    UDI-DI
    90685447000207
    PMA / PMN Number
    K073326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY THAT OCCURRED.

    Description of Event or Problem · 1

    THE NRG TRANSSEPTAL NEEDLE CAUSED A HIGH IMPEDANCE ERROR CODE ON THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR WHEN RF DELIVERY WAS ATTEMPTED, RESULTING IN A PROCEDURAL ABORTION AFTER A 20 MINUTE DELAY. THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED USING A NEW NRG TRANSSEPTAL NEEDLE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20 MINUTE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501668 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF NRG-E-HF-71-C0 NGFB150920 90685447000207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other