BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3232922 · Received July 18, 2013

    Report

    Report Number
    9673241-2013-00238
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    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 RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER FAILED CARTO 3 DUE TO RINGS #10 AND #11 WERE BLACKED OUT. AN ELECTRICAL TEST WAS PERFORMED AND THE DEVICE FAILED. IT WAS THEN NOTICED THAT THE CATHETER HAD A CUT BETWEEN THOSE RINGS. THIS CONDITION WAS NOT ORIGINALLY REPORTED. IT IS UNKNOWN HOW THE LUMEN WAS DAMAGED 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 HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THE CUSTOMER WAS UNABLE TO FAM WITH THE LASSONAV CATHETER. ISSUE WAS NOT RESOLVED AFTER REPLACING THE CATHETER CABLE, UNIT REBOOT OR CATHETER REPLACEMENT. THE PHYSICIANS WAS CONTINUING WITH THE PROCEDURE. ON (B)(6) 2013, THE DEVICE WAS RETURNED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THE CATHETER HAD A CUT ON RINGS #10 AND #11. THIS CONDITION WAS NOT ORIGINALLY REPORTED. DUE TO THE CATHETER CONDITION THIS IS NOW A MDR REPORTABLE EVENT. THE ALERT DATE IS RESET TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333658 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15599027L

    Patients

    Seq Age Sex Outcome Treatment
    1