BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3954225 · Received July 24, 2014

    Report

    Report Number
    9673241-2014-00278
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE LOT NUMBER REPORTED WAS 16101959M. 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 A PATIENT, UNDERWENT A PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER, AND A BAD/NO ECG ALL CHANNELS (BS AND ICD) DEVICE MALFUNCTION OCCURRED. IT WAS REPORTED THAT THERE WAS INTERFERENCE OF ALL ELECTRICAL SIGNALS (SURFACE ECG AND INTRACARDIAC SIGNALS) WHEN CONNECTING THE CATHETER. DISCONNECTING THE CATHETER, THE PROBLEM DISAPPEARED. HOWEVER, AT THE RECONNECTION, THE SIGNALS ARE COMPLETELY AFFECTED AGAIN. THE CABLE WAS EXCHANGED AND ERROR 8 OCCURRED. ALL THE CABLES WERE DISCONNECTED FROM THE FRONT OF THE PATIENT INTERFACE UNIT (PIU). AFTER RESTARTING THE PIU AND RECONNECTING OF ALL THE CABLES EXCEPT THE SMART TOUCH UNIDIRECTIONAL, THERE WAS NO PROBLEM. HOWEVER, WHEN THERE WAS CONNECTION OF THE SMART TOUCH UNIDIRECTIONAL, THERE WAS A REOCCURRENCE OF THE ISSUES. THE CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. PER REQUEST, ADDITIONAL CLARIFICATION WAS RECEIVED ON THE EVENT ON JULY 1, 2014. THEY WERE NOT TRYING TO PACE. THE STIMULATION ROUTING WAS SET TO "NONE" ON THE CARTO SYSTEM. "STIM CARTO" WAS SELECTED ON THE EP RECORDING SYSTEM AS USUAL. AND THE PHYSICIAN DID NOT TRY TO PACE ON THE STIMULATOR. THERE WAS NO PACING AND NO ABLATION WHEN THE PROBLEM OCCURRED. THEY WERE AT THE BEGINNING OF THE PROCEDURE, PLUGGING THE CATHETER INTO THE PIU WHEN THE PROBLEM APPEARED. THE CLASSIC BIOTRONIK STIMULATOR WAS BEING USED. THE NOISE WAS EXPERIENCED ON ALL THE BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO AND THE EP RECORDING SYSTEMS. THERE WAS NO AVAILABLE SIGNAL TO MONITOR THE PATIENT HEART RHYTHM. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER-LIKE DEVICE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF ADDITIONAL INFORMATION PROVIDING THE SEVERITY OF THE NOISE ON ALL CHANNELS ON BOTH THE CARTO SYSTEM AND THE RECORDING SYSTEM ON (B)(6) 2014 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433181 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNK_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1