BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® NAV CATHETER

    MDR report key: 3010712 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00081
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K093376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: CARTO 3, MODEL# M-4800-01, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, WHEN PLUGGING IN THIS CATHETER, ALL BS AND IC ECGS WERE LOST AND THE SIGNAL LOSS OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. UNPLUGGING AND RE-PLUGGING IN THE CATHETER DID NOT RESOLVE THE ISSUE AND THEN A HARDWARE ERROR 8 APPEARED ON THE CARTO 3 SYSTEM. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, CATHETER WAS TESTED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, WHEN PLUGGING IN THIS CATHETER, ALL BS AND IC ECGS WERE LOST AND THE SIGNAL LOSS OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. UNPLUGGING AND RE-PLUGGING IN THE CATHETER DID NOT RESOLVE THE ISSUE AND THEN A HARDWARE ERROR 8 APPEARED ON THE CARTO 3 SYSTEM. THE CATHETER WAS REPLACED AND THE PIU REBOOTED AND THE CASE RESUMED WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114575 LASSO® NAV CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1312-01-S 15598580L

    Patients

    Seq Age Sex Outcome Treatment
    1