BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3243750 · Received July 23, 2013

    Report

    Report Number
    2029046-2013-00099
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WILL NOT BE CONDUCTED SINCE ACCORDING TO THE CUSTOMER, THE PRODUCT WAS DISPOSED. DHR COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE FOLLOWING BWI DEVICES WERE IN USE: 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); SOUNDSTAR CATHETER US CATALOG #: SNDSTR10, OEM LOT #: UNKNOWN. REPROCESSED CS CATHETER. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, WHILE TRANSSEPTAL WAS PERFORMED, A PERICARDIAL EFFUSION OCCURRED AND IT WAS CONFIRMED BY A TRANSTHORACIC ECHOCARDIOGRAM. A PERIOCARDIOCENTESIS WAS PERFORMED WITHOUT SUCCESS. A CODE WAS CALLED AND THE PATIENT'S CHEST WAS OPENED TO REMOVE THE FLUID. THE PATIENT WAS STABILIZED AND SENT TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THREE ATTEMPTS HAVE BEEN PERFORMED TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342616 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-04-S UNKNOWN_D-1317-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R