BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 3171038 · Received June 14, 2013

    Report

    Report Number
    3008500478-2013-00442
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED SEPARATION OF THE PRESSURE MONITORING LUER IS INDETERMINABLE. THE MOST LIKELY ROOT CAUSE INCLUDES, HANDLING AND IMPROPER TECHNIQUE DURING PREP OR PLACEMENT, DAMAGE UPON SHIPPING, DAMAGED DURING THE MANUFACTURING PROCESS ALL OF THESE COULD HAVE CONTRIBUTED TO THE LUER SEPARATION. THE MANUFACTURING TEAM WAS MADE AWARE OF THE COMPLAINT, IN ORDER TO INCREASE AWARENESS OF THE COMPLAINT, AND POSSIBLE DEFECTS. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE LOT IS UNKNOWN. HOWEVER THE COMPLAINT DOES NOT WARRANT A CAPA. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT "DURING CASE THE WHITE PLASTIC NEAR STOP COCK BROKE OFF FROM PR9." THERE WAS NO REPORTED PATIENT INJURIES. THE DEVICE WAS SWITCHED OUT FOR ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270541 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1