BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYKANEN RADIOFREQUENCY GUIDEWIRE

    MDR report key: 7043071 · Received November 17, 2017

    Report

    Report Number
    9710452-2017-00033
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K010265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE DEVICE WAS AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT. THE PROCEDURES IN WHICH THE DEVICE ARE USED ARE ASSOCIATED WITH INHERENT RISKS, WHICH ARE INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, THE BAYLIS NYKANEN RF GUIDEWIRE WAS IDENTIFIED AS HAVING BEEN USED IN A PROCEDURE IN WHICH PATIENT COMPLICATIONS WERE REPORTED. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE DEVICE WAS AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: RATHGEBER S, AULD B, DUNCOMBE S, ET AL. OUTCOMES OF RADIOFREQUENCY PERFORATION FOR PULMONARY ATRESIA AND INTACT VENTRICULAR SEPTUM: A SINGLE-CENTRE EXPERIENCE. (2017); 38(1): 170-175. AS PER THIS ARTICLE, "EMERGENCY SURGERY WAS REQUIRED IN ONE PATIENT DUE TO PERFORATION OF THE RVOT DURING RFP. TWO PATIENTS EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA DURING THE PROCEDURE, WITH ONE REQUIRING CARDIOVERSION FOR ATRIAL FIBRILLATION AND THE OTHER HAVING SPONTANEOUS RESOLUTION OF A PRESUMED AUTOMATIC ATRIAL TACHYCARDIA. FURTHER ORAL MEDICAL TREATMENT WAS REQUIRED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU) DURING THE NEXT 72 H. ONE PATIENT HAD AN ACUTE DROP IN OXYGEN SATURATION IN THE PICU ON DAY 1 POST-PROCEDURE AND RESPONDED TO AN INCREASE IN THE PGE INFUSION. THE PGE WAS SUCCESSFULLY WEANED AFTER 4 DAYS. ONE PATIENT REQUIRED ANTI-THROMBOLYTIC THERAPY FOR LEFT FEMORAL ARTERY THROMBOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821878 NYKANEN RADIOFREQUENCY GUIDEWIRE RF PERFORATION PROBE GEI BAYLIS MEDICAL COMPANY INC. RFP-265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R