BEUDAMED
    FDA Adverse Event Other Summary report: N

    BMC RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 2971588 · Received June 29, 2007

    Report

    Report Number
    9710452-2007-00011
    Event Type
    Other
    Date Received
    June 29, 2007
    Report Date
    June 29, 2007
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GEI
    PMA / PMN Number
    K013904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM OCCURRED BECAUSE OF USER ERROR. THE RADIOFREQUENCY GENERATOR BEGINS TO DELIVER RF ENERGY WHEN THE SWITCH IS TURNED ON. THE RF ENERGY CAN BE SET TO BE DELIVERED FOR THE APPROPRIATE DESIRED TIME. THE DELIVERY OF THE RF ENERGY CAN BE DISCONTINUED BEFORE THE SET TIME IS REACHED BY SWITCHING OFF THE RADIOFREQUENCY GENERATOR. THESE DIRECTIONS ARE ADEQUATELY DESCRIBED IN THE USER MANUAL OF THE RADIOFREQUENCY GENERATOR. THE PT WOLD HAVE UNDERGONE OPEN HEART SURGERY IF THE INTERVENTION WITH THE RADIOFREQUENCY WIRE AND BMC RADIOFREQUENCY PUNCTURE GENERATOR WOULD NOT HAVE BEEN ATTEMPTED OR IF THE INTERVENTION WAS ATTEMPTED UNSUCCESSFULLY. SINCE THIS PROBLEM OCCURRED BY USER ERROR, NO IMMEDIATE CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A PT WAS BEING TREATED FOR PULMONARY ATRESIA USING THE NYKANEN RADIOFREQUENCY WIRE IN CONJUNCTION WITH THE BMC RADIOFREQUENCY PUNCTURE GENERATOR. ONCE THE NYKANEN WIRE CROSSED THE SEPTUM, THE PHYSICIAN INSTRUCTED THE NURSE TO DISCONTINUE THE RF ENERGY FROM THE GENERATOR. THE NURSE ASSUMED THAT THE RF ENERGY WOULD BE DISCONTINUED WHEN THE SWITCH IS RELEASED. SHE WAS NOT AWARE THAT SHE NEEDED TO SWITCH THE GENERATOR OFF. THE WIRE CONTINUED TO ADVANCE WHILE RF ENERGY WAS STILL BEING DELIVERED, ULTIMATELY RESULTING IN PERFORATION OF THE MAIN PULMONARY ARTERY. THE PT HAD TO BE TAKEN FOR SURGERY TO CORRECT THIS PERFORATION. THE SURGERY WAS DONE WITHOUT COMPLICATIONS. THE PT WILL BE FOLLOWED UP AS PER THE USUAL POST-OPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BMC RADIOFREQUENCY PUNCTURE GENERATOR ELECTROSURGICAL GENERATOR GEI BAYLIS MEDICAL CO., INC. REP-100-115 012004-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention