BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 5151554 · Received October 15, 2015

    Report

    Report Number
    9710452-2015-00025
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    October 14, 2015
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. DEVICE DISPOSED AT THE HOSPITAL.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: WINKLE, R. A., MEAD, R. H., ENGEL, G., & PATRAWALA, R. A. (2011). LONG-TERM RESULTS OF ATRIAL FIBRILLATION ABLATION: THE IMPORTANCE OF ALL INITIAL ABLATION FAILURES UNDERGOING A REPEAT ABLATION. AMERICAN HEART JOURNAL, 162(1), 193-200. AS PER THIS ARTICLE, "MAJOR PROCEDURAL COMPLICATIONS OCCURRED IN 1.96% OF ALL ABLATIONS (1.66% OF INITIAL AND 2.87% OF REPEAT ABLATIONS, P = .216) AND IN 2.61% OF WOMEN AND 1.72% OF MEN (P = .338). MINOR COMPLICATIONS OCCURRED IN 1.52% OF ALL ABLATIONS (1.90% OF INITIAL AND 0.36% OF REPEAT ABLATIONS, P = .068) AND IN 1.96% OF WOMEN AND 1.34% OF MEN (P = .583). MAJOR AND MINOR COMPLICATIONS COMBINED OCCURRED IN 3.48% OF ALL ABLATIONS (3.65% OF INITIAL AND 3.23% OF REPEAT ABLATIONS, P = .852). NO PATIENT EXPERIENCED DEATH, ATRIAL-ESOPHAGEAL FISTULA, OR PV STENOSIS REQUIRING INTERVENTION. A SINGLE VEIN HAD A STENOSIS >50%. ONE OF THE THREE PATIENTS WITH STROKES HAD COMPLETE RECOVERY, AND 2 HAD MINOR RESIDUAL DEFICITS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684305 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other