BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1267906 · Received November 12, 2008

    Report

    Report Number
    9673241-2008-00046
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 27, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. BIOSENSE WEBSTER BECAME AWARE OF THIS REPORTABLE MALFUNCTION UPON EVALUATION OF THE COMPLAINT PRODUCT WHICH WAS COMPLETED ON 11/06/2008. THE RESULTS OF THE INVESTIGATION CONFIRMED SOFT PU AS THE ROOT CAUSE. MANUFACTURER ANALYSIS LAB ATTRIBUTED THIS TO AN INTERMITTENT PU MIXER FAILURE. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PRODUCT FOR CONTRACTION PROBLEMS WITH THE LASSO LOOP. UPON RECEIPT, IT WAS NOTED THAT THE TIP WAS SEPARATED AT THE TIP TO SHAFT TRANSITION. NO PT INJURY WAS REPORTED. THE ADDITIONAL INFORMATION THE COMPANY REPRESENTATIVE PROVIDED DID NOT INDICATE THAT THE CUSTOMER WAS AWARE OF THE CONDITION WHEN THEY RETURNED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELETRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-02-S 13396798

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK