BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2812314 · Received October 31, 2012

    Report

    Report Number
    9673241-2012-00308
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION AS INITIALLY REPORTED. DEVICE HISTORY RECORDS 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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM US CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP US CATALOG #: CFP002, SERIAL #: (B)(4). REPROCESSED CATHETER BIDIRECTIONAL CS F/J CATALOG #: BD710FJ282RT. REPROCESSED LASSO CATHETER CATALOG #: D7L1020RT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, WHILE ABLATING IN THE SEPTUM AREA AT 45 WATTS, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE DROPPED INTO THE 70S AND THE HEART RATE WAS DECREASING. A STAT ECHO CONFIRMED A PERICARDIAL EFFUSION. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED NEXT DAY OF THE PROCEDURE. 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, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY 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 CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FURTHERMORE, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. FINALLY, AN IRRIGATION TEST WAS ALSO PERFORMED AND CATHETER FAILED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBING AT THE MIDDLE OF THE SHAFT AREA WAS OCCLUDED WITH CRYSTALLINE MATERIAL. THE CRYSTALLINE MATERIAL WAS ANALYZED, AND RESULTS SHOWED THE MATERIAL WAS COMPOSED OF ELEMENTAL CARBON, OXYGEN, CHLORINE AND SODIUM; IT IS POSSIBLE THAT SOME OF THE ELEMENTS FOUND (CHLORINE AND SODIUM) CAME FROM SALINE SOLUTION; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. NO OTHER FOREIGN MATERIALS WERE FOUND INSIDE THE IRRIGATION TUBING. THE CATHETER FAILED IRRIGATION TEST. HOWEVER, THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, WHILE ABLATING IN THE SEPTUM AREA AT 45 WATTS, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE DROPPED INTO THE 70'S AND THE HEART RATE WAS DECREASING. A STAT ECHO CONFIRMED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 500 CC OF FLUID WERE DRAINED. THE OUTCOME OF THE EVENT WAS REPORTED AS FULLY RECOVERED. THE PHYSICIAN'S STATED THAT WAS UNSURE IF THE CAUSALITY OF THE EFFUSION WAS DUE TO THE PATIENT WAS ON PRODAXA AND BURNING AT 45 WATTS. ALSO THE PHYSICIAN MENTIONED THAT THIS WAS A REDO PROCEDURE, THE FIRST CASE WAS WITH RF AND CONVERTED TO CRYO. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED NEXT DAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-18-S 15671189M

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R