BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11615142 · Received April 5, 2021

    Report

    Report Number
    9710452-2021-00020
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    August 13, 2020
    Report Date
    April 5, 2021
    Product Code
    DXF
    UDI-DI
    90685447000245
    PMA / PMN Number
    K073326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY.

    Description of Event or Problem · 1

    THE NRG TRANSSEPTAL NEEDLE WAS KINKED WHILE THE PHYSICIAN WAS ATTEMPTING TO PUNCTURE THE SEPTUM IN A PATIENT WITH CONGENITAL HEART DEFECT AND MUSTARD REPAIR, RESULTING IN A 20-MINUTE PROCEDURAL DELAY. THE NRG TRANSSEPTAL NEEDLE WAS USED WITH AGILIS STEERABLE INTRODUCER SHEATH (ABBOTT). TRANSSEPTAL PUNCTURE WAS COMPLETED USING A BRK NEEDLE AND THE BOVIE METHOD . 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
    510960 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF NRG-E-HF-98-C0 NGFF280119 90685447000245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other