BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDUIT CABLE TIE TOOL

    MDR report key: 1023711 · Received January 14, 2008

    Report

    Report Number
    1023711
    Event Type
    Injury
    Date Received
    January 14, 2008
    Date of Event
    December 20, 2007
    Report Date
    January 2, 2008
    Manufacturer
    PANDUIT CORP
    Product Code
    MDM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLACEMENT OF HEARTMATE LVAD (LEFT VENTRICULAR ASSIST DEVICE) IN 2007. LVAD CANNULAS SECURED WITH BANDS (CABLE TIES) PLACED WITH CABLE TIE TOOL. PT TAKEN BACK TO OR FOR CHEST CLOSURE 3 DAYS LATER. INFLOW CANNULA IN GOOD POSITION. AFTER STERNUM CLOSED AND DURING MANIPULATION OF INFLOW CANNULA INTO POSITION USING MINIMAL TORQUE, THE ANESTHESIOLOGIST NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY THAT THE INFLOW CANNULA APPEARED MALPOSITIONED. UPON FURTHER INSPECTION, THE SURGEON NOTED THAT THE INFLOW CANNULA HAD DISLODGED FROM THE INTACT SEWING CUFF SUTURED TO THE APEX OF THE HEART RESULTING IN IMMEDIATE EXSANGUINATION. SURGEON NOTED THAT BANDS HAD SLIPPED OFF INFLOW CANNULA. TWO INTACT BANDS FOUND IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANDUIT CABLE TIE TOOL NONE MDM PANDUIT CORP GS2B CR 703M5483

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R| S