BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS THERMOCOOL

    MDR report key: 2200527 · Received August 11, 2011

    Report

    Report Number
    2029046-2011-00074
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT NONE OF THE BWI PRODUCTS CAUSED THIS ISSUE AND NO SERVICE IS REQUESTED AT THIS TIME. THE CATHETERS INVOLVED IN THIS EVENT WERE DISCARDED AND WILL NOT BE RETURNED TO BWI FOR ANALYSIS. IF THE CATHETER IS RETURNED TO BWI FOR ANALYSIS, AN INVESTIGATION WILL BE PERFORMED AND A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # FG540000, SERIAL # (B)(4). COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, SERIAL # (B)(4). STOCKERT RF GENERATOR, CATALOG # S7001, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A VT ABLATION PROCEDURE, THERE WAS A PERFORATION IN THE RVOT. THERE WAS NO INDICATION THAT THERE WAS ANY MALFUNCTION WITH THE EQUIPMENT. CALLER STATED THAT THE DOCTOR PUSHED TOO HARD. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS THERMOCOOL CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) CELSIUS TC UNKNOWN_CELSIUS TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R