BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR SHUNT

    MDR report key: 3241632 · Received July 22, 2013

    Report

    Report Number
    3008500478-2013-00478
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K990396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THERE WAS A BIG POINT OF GLUE ON THE DEVICE WAS CONFIRMED. AN EXCESSIVE USE OF ADHESIVE APPEARED IN THE MIDDLE OF THE SHUNT SHAFT THE DEFECT WAS CONFIRMED, AND A MANUFACTURING DEFECT WAS CONFIRMED. THE ROOT CAUSE IS THAT EXCESS ADHESIVE WAS ADDED TO THE SHUNT DURING THE MANUFACTURING OF THE DEVICE. A SUPPLIER AND EDWARDS¿S CORRECTIVE ACTION HAVE BEEN OPEN AND ARE CURRENTLY UNDER INVESTIGATION. A PRODUCT RECALL HAS BEEN INITIATED. THE DEVICE USE ALIGNED WITH THE INTENDED USE OF THE DESIGN. THE LABELING AND IFU CONTAIN ADEQUATE WARNINGS A PRODUCT RECALL HAS BEEN INITIATED DUE TO THESE COMPLAINTS. THE LOT HISTORY WAS REVIEWED, AND THERE WERE NO RELATED NCRS. FROM JULY 01, 2011 TO JULY 29, 2013 THE COMPLAINT TREND WAS FOUND TO BE OUT OF CONTROL. TRENDS WILL CONTINUE TO BE MONITORED THROUGH EDWARDS¿S QUALITY SYSTEMS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE INTRAVASCULAR SHUNT THAT "IT WAS FOUND DURING USE THAT EXCESSIVE AMOUNT OF ADHESIVE WAS APPLIED ON THE SHAFT WHERE THE TETHER WAS ATTACHED AND BECAME LIKE A LUMP. THE CUSTOMER COMMENTED THAT THE LUMP WAS TOO BIG THAT IT WAS IN THE WAY OF THE PROCEDURE OF INSERTING AND REMOVING THE SHAFT. ALSO, IT WAS SUSPECTED THAT THE POSITION OF THE SHAFT WAS MOVED BECAUSE OF THE LUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341435 INTRAVASCULAR SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES IVS1512 59409889

    Patients

    Seq Age Sex Outcome Treatment
    1