BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1081713 · Received July 4, 2008

    Report

    Report Number
    9673241-2008-00024
    Event Type
    Malfunction
    Date Received
    July 4, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 26, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    9673241-03/25/08-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. EVALUATION OF THE COMPLAINT SAMPLE FOUND THAT THE CATHETER FAILED DEFLECTION TEST, DUE TO JAMMED DEFLECTION MECHANISM. BIOSENSE WEBSTER BECAME AWARE OF THIS REPORTABLE MALFUNCTION, UPON EVALUATION OF THE COMPLAINT PRODUCT WHICH WAS COMPLETED ON 05/12/08. ALL UNUSED VARIABLE LASSO CATHETERS THAT WERE DISTRIBUTED PRIOR TO 03/25/08 - WHICH COULD POTENTIALLY DISPLAY THIS FAILURE MODE - HAVE BEEN REMOVED FROM THE FIELD. A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE LASSO CATHETER WAS "STICKING IN THE LOCKED POSITION" DURING A LEFT ATRIAL FIBRILLATION MAPPING, AND TREATMENT PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS CONTINUED WITHOUT DIFFICULTY, AFTER REPLACING THE CATHETER WITH ANOTHER SIMILAR CATHETER.

    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 13272169

    Patients

    Seq Age Sex Outcome Treatment
    1