BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYKANEN RADIOFREQUENCY WIRE KIT

    MDR report key: 6961300 · Received October 19, 2017

    Report

    Report Number
    9710452-2017-00030
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K010265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT IN QUESTION CONFIRMED ALL PARTS MET MANUFACTURING REQUIREMENTS PRIOR TO RELEASE. THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED PATIENT COMPLICATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE AND IS IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT THE NYKANEN RF WIRE KIT USED IN THE PROCEDURE CAUSED OR CONTRIBUTED TO THE INCIDENT, THIS REPORT IS BEING SUBMITTED BY BAYLIS MEDICAL COMPANY AS THE NYKANEN RF WIRE KIT WAS ONE OF THE DEVICES USED WHEN THE PROCEDURAL COMPLICATION OCCURRED.

    Description of Event or Problem · 1

    THE BAYLIS MEDICAL COMPANY NYKANEN RADIOFREQUENCY (RF) WIRE KIT (RFK-265) WAS USED DURING A PULMONARY ATRESIA PROCEDURE. THE RFK-265 WAS USED WITH A GADELIUS MEDICAL MICROCATHETER. SOME RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE RF WIRE THROUGH THE MICROCATHETER. HOWEVER, RF ENERGY WAS ABLE TO BE SUCCESSFULLY DELIVERED ALTHOUGH NO PUNCTURE WAS ACHIEVED. TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED FOLLOWING RF ENERGY DELIVERY. THE APPROXIMATELY 3 MINUTES FOLLOWING RF ENERGY DELIVERY, VENTRICULAR FIBRILLATION (VF) OCCURRED. THE RF WIRE WAS RETRACTED INSIDE THE MICROCATHETER AT THE ONSET OF VF. CARDIOVERSION WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHILE RECEIVING CARDIAC MASSAGE. THE VF CEASED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS NOT COMPLETED DUE TO THE PROCEDURAL COMPLICATION. THE CAUSE OF THE VF COULD NOT BE CONFIRMED. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE USED IN THE PROCEDURE CAUSED OR CONTRIBUTED TO THE INCIDENT, THIS REPORT IS BEING SUBMITTED BY BAYLIS MEDICAL COMPANY AS THE NYKANEN RF WIRE KIT WAS ONE OF THE DEVICES USED WHEN THE PROCEDURAL COMPLICATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740358 NYKANEN RADIOFREQUENCY WIRE KIT RF PERFORATION PROBE GEI BAYLIS MEDICAL COMPANY INC. RFK-265 RKFA211116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other