BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2840954 · Received November 20, 2012

    Report

    Report Number
    9673241-2012-00333
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS INVESTIGATION COULD NOT BE PERFORMED SINCE THE CATHETER WAS DISPOSED. THE DHR REVIEW COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: CARTO 3 SYSTEMUS: CATALOG #: FG540000 SERIAL #: (B)(4); STOCKERT 70 SYSTEM US: CATALOG #: S7001 SERIAL #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE ROOF OF THE PATIENT'S LEFT ATRIUM WAS PERFORATED DURING ABLATION AT 30 WATTS. THE PERFORATION WAS NEAR THE RIGHT SUPERIOR PULMONARY VEIN. THE PATIENT'S BLOOD PRESSURE DROPPED AND ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION, WHICH TURNED INTO A TAMPONADE. A PERICARDIAL WINDOW WAS PERFORMED. THE PATIENT WAS TAKEN INTO SURGERY AND THE PERFORATION WAS REPAIRED VIA STERNOTOMY. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION.

    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-1197-17-S UNKNOWN_D-1197-17-S_JUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R