BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 2955296 · Received February 11, 2013

    Report

    Report Number
    3008500478-2013-00384
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MISPLACED IN ERROR BY THE CUSTOMER AND UNAVAILABLE FOR EVALUATION. SINCE THE DEVICE IN QUESTION WAS NOT RETURNED, ANY MANUFACTURING DEFECT WITH THE DEVICE CANNOT BE ASSESSED. HOWEVER, IT IS LIKELY THAT THE ROOT CAUSE OF THE INTRODUCER LEAKING IS RELATED TO THE ROOT CAUSE ATTRIBUTED TO SIMILAR COMPLAINTS RECEIVED FOR THE INTRORC LEAKING THAT HAVE BEEN CONFIRMED. THE ROOT CAUSE OF THE LEAKING HAS BEEN DETERMINED TO BE A MATERIAL RELAXATION ISSUE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. A CORRECTIVE ACTION HAS BEEN INITIATED ALONG WITH A PRODUCT RECALL FOR THE INTRODUCER. MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED AS THE LOT IS UNKNOWN. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE TO BE EVALUATED UNPON PRODUCT RETURN FROM THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE INTRODUCER ON THE PROPLEGE CORONARY SINUS DEVICE, PR9 WAS LEAKING. THE DEVICE IS AVAILABLE FOR RETURN. UNKNOWN LOT NUMBER. NO STATED PT INJURY OR PROLONGED OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58379 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1