BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1203295 · Received October 14, 2008

    Report

    Report Number
    2029046-2008-00034
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION IS STILL IN PROGRESS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION PROCESS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THERE WAS A BEND IN THE LOOP ON THIS CATHETER. THIS WAS DISCOVERED BEFORE USE. THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER IS NOT INDICATIVE OF A REPORTABLE COMPLAINT. HOWEVER, UPON RECEIVING THE COMPLAINT SAMPLE, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS SEPARATED FROM THE SHAFT, WHICH REPRESENTS A REPORTABLE MALFUNCTION.

    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. (IRWINDALE) D-1237-0-D UNK_D-1237-

    Patients

    Seq Age Sex Outcome Treatment
    1