BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE

    MDR report key: 2123681 · Received June 14, 2011

    Report

    Report Number
    3008500478-2011-00106
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 8, 2011
    Report Date
    September 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K860497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON UNABLE TO DEFLATE.

    Additional Manufacturer Narrative · 1

    NOT A REPORTABLE EVENT; NO DEFECT FOUND. DEVICE EVALUATION: THE (B)(4) DEVICE WAS EVALUATED BY MANUFACTURING ENGINEERING AND QUALITY ENGINEERING AND THE BALLOON DEFLATION ISSUE WAS NOT CONFIRMED. THE 15 MM BALLOON WAS INFLATED WITH 3 ML OF AIR THROUGH THE BLUE VALVE AND THE 9 MM BALLOON WAS INFLATED WITH 1 ML OF AIR THROUGH THE WHITE VALVE. THE BALLOONS INFLATED AND DEFLATED NORMALLY. THE ROOT CAUSE OF THE SURGEON'S INABILITY TO DEFLATE THE BALLOON COULD NOT BE DETERMINED. THE SOURCE OF THE BALLOON'S INABILITY TO DEFLATE COULD NOT BE TRACED TO A MANUFACTURING ERROR. A DHR WAS PERFORMED AND NO NONCONFORMITIES RELATED TO BALLOON INFLATION OR DEFLATION WAS OBSERVED DURING THE MANUFACTURE OF LOT 58900601. THIS EVENT DID NOT LEAD TO THE 3 SIGMA THRESHOLD BEING EXCEEDED WITHIN THE CSS CPM TREND REPORT FOR CAROTID SHUNTS THEREFORE A CAPA WILL NOT BE INITIATED. THE INFORMATION WILL BE INCLUDED IN TREND DATA AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    AS REPORTED, THE SURGEON TRIED TO DEFLATE THE BALLOON DURING SURGERY AND IT WOULDN'T DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE CAROTID SHUNT DWF EDWARDS LIFESCIENCES T3103B 58900601

    Patients

    Seq Age Sex Outcome Treatment
    1