BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2003328 · Received March 1, 2011

    Report

    Report Number
    2090040-2011-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ASCENT
    Product Code
    NLH
    PMA / PMN Number
    K012708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION. THE COMPLAINT FACILITY DID PROVIDE PHOTOGRAPHS OF THE DEVICE. ASCENT ATTEMPTED TO RE-CREATE THE REPORTED ISSUE WITH THREE DIFFERENT SAMPLE DEVICES FROM ASCENT'S INVENTORY. THE SAMPLE DEVICES WERE EXAMINED FOR THE POSSIBILITY OF AN INHERENT CRACK OR BREAK IN THE ELECTRODE SEALS. IT WAS DETERMINED THAT THERE WERE NO JOINT-SEAL ERRORS OR ELECTRODE SEPARATION POINTS. THE POSSIBILITY OF THE CATHETER CATCHING ON THE SHEATH WAS EXAMINED BY INSERTING THE SAMPLE DEVICES INTO A SAMPLE SHEATH. THE CATHETERS WERE ABLE TO BE SUCCESSFULLY INSERTED AND REMOVED FROM THE SHEATH WITHOUT CATCHING AND THE DEVICES REMAINED FULLY INTACT. THERMAL FACTORS WERE EXAMINED BY EXPOSING ONE OF THE SAMPLE DEVICES TO A FLAME. THE POLYMER MELTED AWAY WITHIN SECONDS RESEMBLING THE IMAGE OF THE ACTUAL DEVICE. THERE IS A POSSIBILITY OF A THERMAL FACTOR GENERATED BY ANOTHER DEVICE AS THE REPORT STATED MULTIPLE CATHETERS WERE BEING USED WITH THE COMPLAINT DEVICE. THIS IS THE FIRST COMPLAINT FOR THE SHEATHING SEPARATING FROM THE ELECTRODE WIRES THAT ASCENT HAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER "WAS REMOVED FROM THE PATIENT, THE INSULATION SHEATHING WAS SEPARATED FROM THE ELECTRODE WIRES." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLH NLH ASCENT 401443

    Patients

    Seq Age Sex Outcome Treatment
    1