BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR SHUNT

    MDR report key: 3171199 · Received June 14, 2013

    Report

    Report Number
    3008500478-2013-00443
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 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

    THE DEVICE IS CURRENTLY UNDER EVALUATION FOR ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE COMPLAINT OF EXCESSIVE ADHESIVE WAS CONFIRMED. THERE WERE NO FURTHER DEFECTS NOTED WITH THE CATHETER. THE ROOT CAUSE IS THAT EXCESS ADHESIVE WAS ADDED TO THE SHUNT DURING THE MANUFACTURING OF THE DEVICE. THIS WAS CAUSED BY INADEQUATE PROCESS CONTROLS AT THE SUPPLIER, AND INCORRECT IDENTIFICATION OF POTENTIAL FAILURE MODE. EDWARDS IS CURRENTLY IN THE PROCESS OF UPDATING THE DRAWING TO INCLUDE SPECIFICATIONS AROUND THE AMOUNT OF ADHESIVE THAT CAN BE USED. A SUPPLIER CAR HAS ALSO ISSUED AND IS IN INVESTIGATION MODE. MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND FOUND ACCEPTABLE AT THE TIME OF DISTRIBUTION. TRENDS WILL CONTINUE TO BE EVALUATED THROUGH THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION REGARDING THIS EVENT. THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT RECALL IN ADDITION FOR THE SUPPLIER CAR. TRENDS WILL CONTINUE TO BE MONITORED THROUGH EDWARDS QUALITY SYSTEM AND ADDITIONAL INFORMATION RELAYED AS DISCOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE ANASTAFLO SHUNT (IVS1530) THE CUSTOMER NOTICED, BEFORE USE THAT THE ADHESIVE WAS "OVERFLOWED ON THE SHAFT WHERE THE TETHER WAS ATTACHED AND BECAME LIKE A LUMP." NO PATIENT CONTACT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270565 INTRAVASCULAR SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES IVS1530

    Patients

    Seq Age Sex Outcome Treatment
    1