BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1081715 · Received July 4, 2008

    Report

    Report Number
    9673241-2008-00025
    Event Type
    Malfunction
    Date Received
    July 4, 2008
    Date of Event
    March 6, 2008
    Report Date
    May 7, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVENT DESCRIPTION, THE FAILURE MODE ASSOCIATED WITH THIS COMPLAINT APPEARS TO BE SIMILAR TO THE FAILURE MODE THAT PROMPTED THE VARIABLE LASSO RECALL. ALL UNUSED VARIABLE LASSO CATHETERS THAT WERE DISTRIBUTED PRIOR TO 2008- WHICH COULD POTENTIALLY DISPLAY THIS FAILURE MODE - HAVE BEEN REMOVED FROM THE FIELD. VARIABLE LASSO CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASSO CATHETER WAS NOT RESPONDING TO DESIRED MOVEMENTS DURING THE PROCEDURE AND IT WAS IMPOSSIBLE TO CHANGE ITS DIAMETER. NO PT INJURY WAS 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-1237-02-S 13310427

    Patients

    Seq Age Sex Outcome Treatment
    1