BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2962101 · Received February 14, 2013

    Report

    Report Number
    9673241-2013-00034
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING THE END OF AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS NOTED THAT ALL SIGNALS, INTRACARDIAC (IC) AND BODY SURFACE (BS) ECG'S WERE LOST ON BOTH THE BARD SYSTEM AND THE CARTO 3 SYSTEM. ALL THE CABLES AND CATHETERS WERE DISCONNECTED. ALL RELEVANT CABLES WERE REPLACED. IT WAS NOTED THAT WHEN DISCONNECTING THE C3 NAV VARIABLE LASSO CATHETER, ALL SIGNALS RETURNED ON ALL SYSTEMS. THE C3 NAV VARIABLE LASSO CATHETER CABLE WAS REPLACED WITH A NEW ONE, BUT THE PROBLEM STILL PERSISTED. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS AND REPLACED WITH A NEW CATHETER AND THE PROBLEM WAS RESOLVED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN, PER THE EVENT REPORTED, THE CATHETER WAS ELECTRICALLY TESTED AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE END OF AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS NOTED THAT ALL SIGNALS, INTRACARDIAC (IC) AND BODY SURFACE (BS) ECG'S WERE LOST ON BOTH THE BARD SYSTEM AND THE CARTO 3 SYSTEM. ALL THE CABLES AND CATHETERS WERE DISCONNECTED. ALL RELEVANT CABLES WERE REPLACED. IT WAS NOTED THAT WHEN DISCONNECTING THE C3 NAV VARIABLE LASSO CATHETER, ALL SIGNALS RETURNED ON ALL SYSTEMS. THE C3 NAV VARIABLE LASSO CATHETER CABLE WAS REPLACED WITH A NEW ONE, BUT THE PROBLEM STILL PERSISTED. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS AND REPLACED WITH A NEW CATHETER AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66057 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15707420L

    Patients

    Seq Age Sex Outcome Treatment
    1