BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2071233 · Received April 27, 2011

    Report

    Report Number
    9673241-2011-00038
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TWO DIFFERENT FAILURES ON THIS CATHETER: ERRORS 8 AND 139 ON THE CARTO 3 SYSTEM; AND THE MICRO BUBBLES SEEN ON THE ULTRASOUND SYSTEM. THE RETURNED DEVICE WAS TESTED AND PASSED ELECTRICAL AND LEAKAGE TESTS. THE CATHETER WAS TESTED AND PASSED EEPROM, HOWEVER FAILED CARTO AND RECALIBRATION TESTS DUE TO MAGNETIC SENSOR DISCONNECTION. THE CATHETER WAS ANALYZED WITH AN ULTRASOUND CATHETER. NO MICRO BUBBLES WERE OBSERVED IN THIS TEST. THEREFORE, THE CATHETER WAS SENT TO THE SYSTEM TECHNOLOGY CENTER TO BE ANALYZED ALONG WITH THE CUSTOMER'S CARTO 3 SYSTEM. THE MICRO BUBBLES PROBLEM STILL COULD NOT BE DUPLICATED. IN ADDITION, THE MICRO BUBBLES OBSERVED ON THE ULTRASOUND IMAGE WAS NOT RELATED TO THE MAGNETIC SENSOR DISCONNECTION THAT IS SHOWN IN THE ANALYSIS. THE ROOT CAUSE OF THE REPORTED MICRO BUBBLES COULD NOT BE DETERMINED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS 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. COMPLAINT CONDITION REGARDING ERROR 8 COULD NOT BE REPRODUCED; COMPLAINT CONDITION ABOUT ERROR 139 MESSAGE ON CARTO 3 SYSTEM WAS CONFIRMED. MICRO BUBBLES CONDITION CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. BIOSENSE WEBSTER MANUFACTURER'S REF NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE USER ENCOUNTERED A PACE ROUTING ERROR CODE 8 ON THE CARTO SYSTEM. THERE WAS ALSO CURRENT LEAKAGE FROM THE LASSO NAV CATHETER FOR APPROXIMATELY TEN MINUTES . THE GENERATOR WAS SET TO POWER CONTROL MODE, AND THERE WAS NO ABLATION CATHETER IN THE LEFT ATRIUM. THEY WERE TRYING TO PACE THE CRISTA AND CS CATHETER. THE CURRENT WAS VISUALIZED AS BUBBLES FROM THE ULTRASOUND IMAGE. THIS CONTINUED AFTER THE SYSTEM WAS SHUT DOWN AND REBOOTED. THERE WAS NO PACING ATTEMPTED POST TRANSSEPTAL ACCESS. THE CARTO SYSTEM ALSO DISPLAYED ERROR CODE 139 (THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED). THE LASSO CABLE WAS EXCHANGED. THE PROBLEM PERSISTED. THE CUSTOMER WAS TRYING TO PACE THROUGH THE CRISTA CATHETER AND THE CS CATHETER AND WAS HAVING PROBLEMS. THE UNIT WAS ALSO HAVING PROBLEMS WITH FAM OR TAKING ABLATION POINTS. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15337118L

    Patients

    Seq Age Sex Outcome Treatment
    1