BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3232763 · Received July 18, 2013

    Report

    Report Number
    9673241-2013-00235
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE ECG SIGNALS DISAPPEARED AND ECG SIGNALS FROM OTHER CATHETERS WERE DISTORTED UPON CONNECTION OF THE NAVISTAR THERMOCOOL CATHETER. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL CLARIFICATION ON THE EVENT. THE SIGNAL LOSS OCCURRED ON ALL THE BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO SYSTEM AND THE RECORDING SYSTEM AT THE SAME TIME. THIS ISSUE OCCURRED IMMEDIATELY UPON CONNECTION OF THIS CATHETER. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY CHANGING THIS CATHETER. THE SIGNAL LOSS ON ALL THE CHANNELS ON BOTH THE CARTO SYSTEM AND THE RECORDING SYSTEM AT THE SAME TIME IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334894 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15577811M

    Patients

    Seq Age Sex Outcome Treatment
    1