BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3885317 · Received June 19, 2014

    Report

    Report Number
    9673241-2014-00227
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 26, 2014
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE LOT # 16068748L WAS PROVIDED, THE DEVICE HISTORY RECORD(S) 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. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON NOVEMBER 7, 2014. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO NAV ECO VARIABLE CATHETER AND THERE WAS NOISE ON ALL SIGNALS MAKING DIFFICULT FOR THE PHYSICIAN TO MONITOR PATIENT HEART RHYTHM. AFTER 30 MINUTES OF THE CATHETER BEING USED, THIS ISSUE OCCURRED WHILE ABLATING. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE 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. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS RESULTS USING MONTHLY COMPLAINT TREND REPORTING. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THERE WAS NOISE ON ALL SIGNALS MAKING DIFFICULT FOR THE PHYSICIAN TO MONITOR PATIENT HEART RHYTHM. AFTER 30 MINUTES OF THE CATHETER BEING USED, THIS ISSUE OCCURRED WHILE ABLATING. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361329 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S UNKNOWN_D-1343-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1