BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NYKANEN RADIOFREQUENCY WIRE KIT

    MDR report key: 15810261 · Received November 16, 2022

    Report

    Report Number
    9710452-2022-00049
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K010265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PHYSICIAN HAD A JR2 CATHETER (CONTAINING CORONARY WIRE AND PROTRACK MICROCATHETHER) POSITIONED UNDER THE ATRETIC PULMONARY VALVE; WHEN THE CORONARY WIRE WAS EXCHANGED FOR NYKANEN. THE NYKANEN WIRE WAS STRAIGHTENING OUT THEIR JR2 CATHETER, AND THEY NO LONGER HAD A GOOD POSITIONING UNDER THE VALVE. PHYSICIAN OPTED FOR STIFF BACK END OF GUIDEWIRE AND MECHANICALLY CROSSED THROUGH THE VALVE BECAUSE THEY COULD NOT GET GOOD POSITIONING WHEN USING THE NYKANEN WIRE. WHILE THERE WAS NO ADVERSE EVENT RELATED TO THE USE OF THE BAYLIS MEDICAL DEVICE, BAYLIS MEDICAL TECHNOLOGIES CONSIDERS A DEVICE MALFUNCTION LEADING TO A SURGICAL DELAY OF GREATER THAN 15 MINUTES TO BE AN FDA REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782555 NYKANEN RADIOFREQUENCY WIRE KIT RF PERFORATION PROBE GEI BAYLIS MEDICAL COMPANY INC. RFK-265 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other