BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORONTO TRANSSEPTAL CATHETER

    MDR report key: 1362616 · Received April 14, 2009

    Report

    Report Number
    9710452-2009-00001
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    March 16, 2009
    Report Date
    April 8, 2009
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DXF
    PMA / PMN Number
    K031949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED BY MANUFACTURER FOR EVALUATION, BUT WAS NOT AVAILABLE. TECHNICAL INVESTIGATION ON SIMILAR DEVICES WAS CONDUCTED AND REVISED WITH PHOTOGRAPHS OF THE DEVICE AND PHYSICIAN'S COMMENTS. THE CAUSE OF THE DEVICE BREAKAGE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INCIDENT IS CONSIDERED AN UNANTICIPATED ADVERSE EVENT. OVER 1180 DEVICES HAVE BEEN SOLD SO FAR, AND THIS HAS BEEN THE FIRST KNOWN OCCURRENCE OF TIP DETACHMENT REPORTED. THE MANUFACTURER WILL CONTINUE TO MONITOR THESE KINDS OF INCIDENTS FOR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR ATRIAL FIBRILLATION. THE PHYSICIAN ATTEMPTED TRANSSEPTAL PUNCTURE USING TORONTO TRANSSEPTAL CATHETER. AFTER THE PROCEDURE WAS UNSUCCESSFUL, THE TORONTO TRANSSEPTAL CATHETER WAS EXAMINED, AND IT WAS FOUND THAT THE ACTIVE CATHETER TIP WAS EMBEDDED INTO THE INTERATRIAL SEPTUM. THERE WAS NO EVIDENCE OF SEPTAL HEMATOMA, PERICARDIAL EFFUSION OR HEMODYNAMIC INSTABILITY IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORONTO TRANSSEPTAL CATHETER SEPTOSTOMY CATHETER DXF BAYLIS MEDICAL CO., INC. TSC-50-75 TSFA040407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other