BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO 2525 NAV VARIABLE CATHETER

    MDR report key: 2140531 · Received June 22, 2011

    Report

    Report Number
    MW5021105
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETING ABLATION OF LEFT SUPERIOR VEIN USING A BIOSENSE WEBSTER LASSO CATHETER, PHYSICIAN PROCEEDED TO LEFT INFERIOR VEIN USING SAME LASSO CATHETER. PHYSICIAN PLACED LASSO CATHETER IN LEFT INFERIOR VEIN VIA CATHETER SHEATH. THE CATHETER HANDLE WAS TURNED CLOCKWISE TO DECREASE THE SIZE OF THE LASSO CATHETER TO GET POSITIONED INSIDE THE VEIN. ONCE INSIDE THE VEIN, IN ATTEMPT TO GET DESIRED POSITIONING, PHYSICIAN CONTINUED TO MANIPULATE CATHETER BY TURNING CATHETER HANDLE CLOCKWISE (TIGHTENING THE LASSO LOOP) AND COUNTERCLOCKWISE (WIDENING THE LASSO LOOP). AFTER SEVERAL ATTEMPTS TO GET TO DESIRED CATHETER POSITIONING, THE CATHETER BECAME "TORQUED". THE PHYSICIAN THEN ATTEMPTED TO GET THE CATHETER "UNTORQUED" BY MANIPULATING THE CATHETER. HOWEVER, THE LASSO CATHETER BECAME TWISTED INTO WHAT APPEARED TO BE A KNOT AT THE TIP. AT THIS POINT, THE PHYSICIAN BECAME CONCERNED THAT THE CATHETER WOULD NOT BE ABLE TO BE PULLED BACK AND REMOVED THROUGH THE SHEATH WITHOUT POTENTIALLY HARMING THE PT. THE PHYSICIAN MADE THE DECISION TO TAKE THE PT TO THE OPERATING ROOM ON (B)(6) 2011 SO THE CARDIOVASCULAR SURGEON COULD ASSIST WITH REMOVAL OF THE CATHETER. THE CATHETER WAS REMOVED IN SURGERY THE SAME DAY WITHOUT INCIDENT. NOTE: THIS WAS A BRAND NEW CATHETER; IT HAD NOT BEEN REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2525 NAV VARIABLE CATHETER LASSO CATHETER DRF BIOSENSE WEBSTER LASSO 2515 NAV 15373118L

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R