BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE AERIS

    MDR report key: 4200005 · Received October 21, 2014

    Report

    Report Number
    8030904-2014-00015
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ST. JUDE MEDICAL SYSTEMS AB
    Product Code
    DXO
    PMA / PMN Number
    K113584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MFR AND IS UNDERGOING INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SJM SPECIFICATION.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT WHEN HE TRIED TO ADVANCE THE PRESSURE WIRE, IT WAS NOT POSSIBLE, AND WHEN HE TRIED TO PULL BACK ON IT, IT GOT STUCK. IT STRIPPED THE SOFT GUIDE PORTION OFF THE WIRE. HE WAS UNABLE TO USE WIRE AFTER THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670000 PRESSUREWIRE AERIS GUDIEWIRE SENSOR DXO ST. JUDE MEDICAL SYSTEMS AB C12058 141585

    Patients

    Seq Age Sex Outcome Treatment
    1