BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3102403 · Received May 9, 2013

    Report

    Report Number
    9673241-2013-00148
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM¿S PATIENT INTERFACE UNIT (PIU). RIGHT AFTER THIS CATHETER CONNECTION, ALL THE SIGNAL CHANNELS WERE INFLUENCED. ALL THE SIGNALS FLUCTUATED INCLUDING THE BODY SURFACE (BS) SIGNALS AND THE INTRA CARDIAC (IC) SIGNALS. THE CONNECTION CABLE WAS CHANGED WITH NO DIFFERENCE. THE CATHETER WAS THEN EXCHANGED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ALL THE BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM WERE LOST AT THE SAME TIME. THE PROCEDURE WAS COMPLETED WITH A NEW LASSO NAVIGATIONAL CATHETER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM¿S PATIENT INTERFACE UNIT (PIU). RIGHT AFTER THIS CATHETER CONNECTION, ALL THE SIGNAL CHANNELS WERE INFLUENCED. ALL THE SIGNALS FLUCTUATED INCLUDING THE BODY SURFACE (BS) SIGNALS AND THE INTRA CARDIAC (IC) SIGNALS. THE CONNECTION CABLE WAS CHANGED WITH NO DIFFERENCE. THE CATHETER WAS THEN EXCHANGED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ALL THE BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM WERE LOST AT THE SAME TIME. THE PROCEDURE WAS COMPLETED WITH A NEW LASSO NAVIGATIONAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203425 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15783053L

    Patients

    Seq Age Sex Outcome Treatment
    1