BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 2962250 · Received February 14, 2013

    Report

    Report Number
    3008500478-2013-00389
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE 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 LEAKING THAT HAVE BEEN CONFIRMED PER ASSESSMENT BY (B)(4) AND QUALITY ENGINEERING OF THE SIMILAR COMPLAINTS WITH RETURNED DEVICES, 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 CAPA HAS BEEN INITIATED FOR THESE COMPLAINTS AND PRODUCT RECALL. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE SALES REP: "AN AVR THROUGH A HEMI-STERNOTOMY WAS PERFORMED USING THE PROPLEGE CATHETER. DR. POSITIONED THE CATHETER AS USUAL, USING THE 11 FR INTRODUCER THAT COMES WITH THE KIT. DURING THE PROCEDURE, THEY NOTED LEAKAGE OF BLOOD FROM THE INTRODUCER. AFTER THE CASE, THEY REMOVED THE PROPLEGE CATHETER, AND KEPT HAVING BLOOD LEAKING FROM THE INTRODUCER. THEY INSERTED THE "BLOCKER" PROVIDED WITH THE INTRODUCER KIT, AND STILL NOTED LEAKAGE BUT OF SOLUTE THIS TIME AS THE BLOCKER WAS CONNECTED TO THEIR SOLUTE." NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64558 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59385204

    Patients

    Seq Age Sex Outcome Treatment
    1