BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3160660 · Received June 10, 2013

    Report

    Report Number
    2029046-2013-00069
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    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 INVESTIGATION WILL NOT BE CONDUCTED SINCE THE DEVICE WAS DISPOSED BY THE ACCOUNT. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED SINCE THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT RECOGNIZED BY OUR SYSTEM. IT COULD NOT BE IDENTIFIED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US 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 IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND A TAMPONADE WAS NOTICED. THE PATIENT EXPERIENCED A TEMPORARY RESPIRATORY ARREST AND THE REPORTER STATED THAT A PERFORATION WAS ALSO SUSPECTED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY A TRANSTHORACIC ECHOCARDIOGRAM (TTE). PERICARDIAL TAP WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE INTUBATED AND IN STABLE CONDITION. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260505 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R