BEUDAMED
    FDA Adverse Event Death Summary report: N

    NYKANEN RADIOFREQUENCY KIT

    MDR report key: 6130870 · Received November 28, 2016

    Report

    Report Number
    9710452-2016-00021
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 28, 2016
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K010265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT INVOLVED CONFIRMED ALL PARTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED PATIENT COMPLICATIONS ARE INHERENT RISKS TO THIS TYPE OF PROCEDURE. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT THE NYKANEN RF WIRE USED IN THE PROCEDURE CAUSED OR CONTRIBUTED TO THE INCIDENT, THIS REPORT IS BEING SUBMITTED BY BAYLIS MEDICAL COMPANY AS THE NYKANEN RF WIRE WAS ONE OF THE DEVICES USED DURING THE PROCEDURE. DEVICE DISCARDED AFTER PROCEDURE.

    Description of Event or Problem · 1

    THE NYKANEN RADIOFREQUENCY (RF) WIRE WAS USED IN A PROCEDURE TO CREATE AN ATRIAL SEPTAL DEFECT IN A PATIENT. SUCCESSFUL PUNCTURE WAS ACHIEVED AFTER DELIVERING RF ENERGY 12 TIMES FROM THE RF GENERATOR. FOLLOWING ATRIAL SEPTAL PUNCTURE, BALLOON DILATION AND BALLOON ATRIAL SEPTOSTOMY WERE PERFORMED, RESULTING IN DISAPPEARANCE OF THE PRESSURE GRADIENT. AT THE END OF THE PROCEDURE, NO PRESSURE GRADIENT WAS OBSERVED BETWEEN THE ATRIUMS. IN ADDITION, NO CARDIAC PERFORATION OR TAMPONADE WAS OBSERVED AS CONFIRMED BY ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. APPROXIMATELY 5 HOURS AFTER THE END OF THE PROCEDURE, BRADYCARDIA WAS OBSERVED IN THE PATIENT. SUBSEQUENTLY, CARDIAC ARREST WAS CONFIRMED AND CARDIAC MASSAGE WAS PERFORMED. THE PATIENT'S HEART RHYTHM WAS RECOVERED. HOWEVER, CARDIAC TAMPONADE WAS OBSERVED AT THIS TIME, WHICH MAY HAVE BEEN ATTRIBUTED TO THE CARDIAC MASSAGE PERFORMED. THE PATIENT WAS MONITORED IN THE ICU; HOWEVER, BRADYCARDIA WAS OBSERVED AGAIN. THE PATIENT WAS IN A LOW PRESSURE CONDITION, AND CARDIAC ARREST WAS AGAIN CONFIRMED. OPEN HEART DRAINAGE AND DIRECT CARDIAC MASSAGE WAS PERFORMED. HOWEVER, PATIENT DEATH OCCURRED. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT THE NYKANEN RF WIRE USED IN THE PROCEDURE CAUSED OR CONTRIBUTED TO THE INCIDENT, THIS REPORT IS BEING SUBMITTED BY BAYLIS MEDICAL COMPANY AS THE NYKANEN RF WIRE WAS ONE OF THE DEVICES USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779155 NYKANEN RADIOFREQUENCY KIT RF PERFORATION PROBE GEI BAYLIS MEDICAL COMPANY INC. RFK-265 RKFA010416

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Congenital Anomaly| D| O| R