BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1082845 · Received July 24, 2008

    Report

    Report Number
    9673241-2008-00033
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE FACILITY'S RISK MANAGEMENT DEPT WILL NOT ALLOW THE LASSO CATHETER TO BE SENT BACK TO BIOSENSE WEBSTER FOR TESTING. CUSTOMER HAS ONLY FORWARDED PICTURES OF THE CATHETER TO BIOSENSE WEBSTER. FROM THE PICTURES RECEIVED, IT APPEARS THAT THE DISTAL PART OF THE LASSO LOOP IS BENT 90 DEGREES; HOWEVER, IT CANNOT BE DETERMINED IF ANY ADDITIONAL DAMAGE IS PRESENT. A ROOT CAUSE INVESTIGATION CANNOT BE PERFORMED SINCE THE CATHETER HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT WHEN THE PHYSICIAN WENT TO WITHDRAW THE LASSO CATHETER FROM THE PT, THERE WAS AN EXTREME AMOUNT OF RESISTANCE. ONCE THE CATHETER WAS REMOVED FROM PT, CUSTOMER NOTED A KINK IN THE TIP OF THE CATHETER. NO ADVERSE EVENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-01-S 13374142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA