BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2840951 · Received November 20, 2012

    Report

    Report Number
    9673241-2012-00332
    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
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WAS NOT CONDUCTED SINCE THE CATHETER WAS DISPOSED. DHR REVIEW COULD NOT BE PERFORMED BECAUSE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US: CATALOG #: FG540000. SERIAL #: (B)(4); STOCKERT 70 SYSTEM US: CATALOG #: S7001, SERIAL #: UNKNOWN; COOL FLOW PUM US: CATALOG #: CFP002, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IDEOPATHIC VT PROCEDURE, THE PATIENT'S HEART RATE INCREASED AND THE BLOOD PRESSURE DECREASED AFTER ABLATING. AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-00 UNKNOWN_TCOOL SF C3

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R