BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3132059 · Received May 29, 2013

    Report

    Report Number
    2029046-2013-00064
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION AS INITIALLY REPORTED. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. MANUFACTURER REFERENCE #:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A TRANSSEPTAL PUNCTURE, THE LASSO CATHETER WAS ADVANCED TO THE LEFT ATRIUM. WHEN CONNECTING THE LASSO 2515 NAV VARIABLE CATHETER TO THE CARTO SYSTEM, HIGH FREQUENCY NOISE APPEARED ON ALL BS AND IC CHANNELS. THE SAME NOISE WAS OBSERVED ON BOTH THE CARTO MAPPING SYSTEM AND THE GE CARDIOLAB ECG RECORDING SYSTEM. THE NOISE WAS CONSTANT. AFTER CONNECTING, THE CARTO SYSTEM DISPLAYED AN ERROR MESSAGE: ¿PACE ROUTING FAILED¿. THE ISSUE WAS RESOLVED BY EXCHANGING THE LASSO WITH A SAME LIKE PRODUCT. THE TROUBLESHOOTING PROCESS DELAYED THE PROCEDURE 20-25 MINUTES. NO COMPLICATIONS WERE OBSERVED DURING THE PROCEDURE. FOLLOW UP WAS PERFORMED TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND IT WAS CONFIRMED THAT THE NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. DUE TO THIS FACT, THE PHYSICIAN WAS NOT ABLE TO INTERPRET BS AND IC SIGNALS MAKING THIS EVENT REPORTABLE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236397 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1290-01-S UNKNOWN_D-1290-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1