BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1024196 · Received March 27, 2008

    Report

    Report Number
    9673241-2008-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 23, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. AFTER THE TWO CATHETERS WERE RECEIVED BY BIOSENSE WEBSTER, PRELIMINARY EVAL RESULTS INDICATED THAT ONE CATHETER WAS RECEIVED LOCKED IN A DEFLECTED POSITION, AND ONE CATHETER WAS RECEIVED LOCKED IN A CONTRACTED POSITION. BIOSENSE WEBSTER BECAME AWARE OF THIS REPORTABLE MALFUNCTION UPON EVAL OF THE COMPLAINT PRODUCT IN 2008. THE PRODUCT EVAL HAS NOT YET BEEN COMPLETED. THIS REPORT WIL BE UPDATED UPON COMPLETION OF PRODUCT EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIAMETER WOULD NOT ADJUST ON THE LASSO CATHETER. IT WAS ALSO REPORTED THAT ANOTHER SIMILAR CATHETER OF LOT# 13267308 (MANUFACTURED DATE: 08/13/2007, EXPIRATION DATE: 07/31/2008) HAD THE SAME PROBLEM: THE DIAMETER WOULD NOT ADJUST.

    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 13267308

    Patients

    Seq Age Sex Outcome Treatment
    1