BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2841070 · Received November 20, 2012

    Report

    Report Number
    9673241-2012-00336
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED, IT WAS IDENTIFIED THAT TWO PIECES WERE SCRAPED; HOWEVER DHR SHOW THE PIECES WERE IDENTIFIED DURING THE PROCESS PRIOR THE FINAL INSPECTION STAGE AND DOCUMENTATION SHOWS THE SCRAP OF THESE PIECES EXIST. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM; MFG #: M-4800-01; SERIAL #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED WHEN INTRODUCING THE THERMOCOOL SF NAVIGATIONAL CATHETER DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, ALL INTRACARDIAC (IC) SIGNALS AND BODY SURFACE (BS) 12-LEAD ECG'S WERE LOST ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM AT THE SAME TIME. 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 CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY THE CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS CLOSED ON (B)(4) 2012 AFTER MULTIPLE REQUESTS WERE MADE TO HAVE THE COMPLAINT PRODUCT RETURNED FOR ANALYSIS AND THE PRODUCT HAD NOT BEEN RECEIVED. THE COMPLAINT WAS RE-OPENED AS THE PRODUCT WAS RECEIVED ON (B)(4) 2013 FOR EVALUATION IN THE BWI FAILURE ANALYSIS LAB. THE PRODUCT INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN INTRODUCING THE THERMOCOOL SF NAV CATHETER, DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THEY LOST ALL SIGNALS. THE BWI FIELD REPRESENTATIVE STATES THAT AT THE BEGINNING OF THE PROCEDURE AN ERROR WAS DISPLAYED FOR NOISE ON THE LOCATION PAD CURRENTS. THE PATIENT INTERFACE UNIT (PIU) WAS REBOOTED AND THAT ERROR WAS NOT SEEN AGAIN, BUT A PACE ROUTING DISABLED ERROR WAS DISPLAYED. THE CATHETERS AND THE 12-LEAD CABLE WERE DISCONNECTED AND THE PIU WAS REBOOTED AGAIN. THE PIU THEN BOOTED UP NORMALLY WITHOUT ERRORS. THE DIAGNOSTIC CATHETERS AND THE BODY SURFACE (BS) 12-LEAD CABLE WERE RECONNECTED WITHOUT ERRORS BEING DISPLAYED. WHEN THE THERMOCOOL SF NAV CATHETER WAS OPENED AND CONNECTED ALL INTRACARDIAC (IC) SIGNALS AND BODY SURFACE (BS) 12-LEAD ECG'S WERE LOST. DISCONNECTING THIS CATHETER BROUGHT THE BS ECG'S BACK. A RESTERILIZED CABLE WAS IN USE. A SECOND RESTERILIZED NAVISTAR CABLE WAS USED WITH SIMILAR RESULTS. A BRAND NEW NAVISTAR CABLE WAS CONNECTED AND ALL BS ECG'S DISAPPEARED AGAIN. THE PIU WAS REBOOTED AGAIN BUT THE CONNECTION OF THE THERMOCOOL SF NAV CATHETER STILL RESULTED IN THE LOSS OF THE BS ECG'S. A DIFFERENT NAVISTAR CATHETER WAS OPENED AND CONNECTED AND THE BS ECG'S WERE DISPLAYED NORMALLY. LATER IN THE SAME PROCEDURE AN ERROR 139 WAS DISPLAYED RELATING TO THE LASSO NAVIGATIONAL CATHETER IN USE. THE LASSO NAVIGATIONAL CATHETER WAS STILL VISIBLE AND THE CASE WAS COMPLETED DESPITE THIS ERROR. AT THE END OF THE PROCEDURE THE INITIAL THERMOCOOL SF NAV CATHETER WAS CONNECTED AND DID NOT RESULT IN THE LOSS OF BS ECG'S AGAIN. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST FROM THE BWI FIELD REPRESENTATIVE, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE SIGNAL LOSS OCCURRED ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM AT THE SAME TIME. THE PACE ROUTING DISABLED ERROR MESSAGE RESOLVED PRIOR TO NEEDING PACING. THE BLOOM STIMULATOR WAS BEING USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15671443L

    Patients

    Seq Age Sex Outcome Treatment
    1