BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANASTAFLO SHUNT

    MDR report key: 3173775 · Received June 17, 2013

    Report

    Report Number
    3008500478-2013-00447
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K990396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CUSTOMER REPORT OF ADHESIVE ISSUE WAS CONFIRMED. THE BONDING PART OF THE SHAFT AND THE TETHER APPEARED LARGER THAN SHAFT BULB DUE TO EXCESSIVE ADHESIVE. NO VISIBLE DAMAGE WAS FOUND FROM THE DEVICE. THE DEVICE IS UNDER CURRENT EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "CUSTOMER NOTICED BEFORE USE THAT THE ADHESIVE WAS OVERFLOWED ON THE SHAFT OF THE ANASTAFLO SHUNT (IVS1512), WHERE THE TETHER WAS ATTACHED AND BECAME LIKE A LUMP." THIS EVENT OCCURREND IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273254 ANASTAFLO SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES IVS1530 59431932

    Patients

    Seq Age Sex Outcome Treatment
    1