BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 3940617 · Received June 26, 2014

    Report

    Report Number
    9710452-2014-00005
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE INVESTIGATION CONFIRMED THERE WAS NO DEVICE FAILURE. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE AND IS IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING THAT CARDIAC TAMPONADE OCCURRED IN A PATIENT UNDERGOING A CARDIAC ABLATION PROCEDURE. THIS REPORT IS BEING SUBMITTED BY BAYLIS MEDICAL AS THE NRG TRANSSEPTAL NEEDLE WAS ONE OF THE DEVICES USED DURING THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ASSEMBLY OF TRANSSEPTAL DEVICES TO THE TARGET PUNCTURE SITE. DURING TENTING AT THE FOSSA OVALIS, THE PHYSICIAN FELT THE ASSEMBLY OF TRANSSEPTAL DEVICES INADVERTENTLY CROSS THE PUNCTURE SITE. NO RF ENERGY WAS APPLIED. THE PHYSICIAN CONTINUED TO ADVANCE THE SHEATH AND FELT SOMETHING UNUSUAL. ANGIOGRAPHY AND ECHOCARDIOGRAM WERE PERFORMED AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED. THE PROCEDURE WAS ABORTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE NRG NEEDLE CAUSED OR CONTRIBUTED TO THE UNEXPECTED PERFORATION IN THE PATIENT, WHICH RESULTED IN THE CARDIAC TAMPONADE. HOWEVER, AS NRG TRANSSEPTAL NEEDLE WAS ONE OF VARIOUS TRANSSEPTAL DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373103 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL CO., INC. NRG-E-HF-71-C0 NGFA041113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other