BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1905247 · Received November 22, 2010

    Report

    Report Number
    9673241-2010-00082
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONDITION WAS STABLE AT THE END OF THE PROCEDURE AND WAS RELEASED SUBSEQUENTLY, HOWEVER, NOT FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT BY THE FACILITY THUS FAR. A FIELD SERVICE ENGINEER WENT ONSITE AND PERFORMED TESTING OF THE SYSTEM AS REQUESTED BY THE MANUFACTURER. SINCE THE SYSTEM WOULD NOT PASS THE ACL VALIDATION TEST, THE DEFECTIVE SYSTEM WAS REPLACED BY A NEW ONE (CARTO 3 SYSTEM, CATALOG # FG540000, (B)(4)). THE CUSTOMER INDICATED THAT NO OTHER EQUIPMENT MALFUNCTIONED AND THAT A SERVICE IS NOT REQUIRED. IF THE CATHETERS INVOLVED IN THE PROCEDURE ARE RETURNED TO BWI IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # FG540000, (B)(4); STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4); COOLFLOW PUMP, CATALOG # CFP002 , (B)(4); LASSO 2515 NAV VARIABLE CATHETER, CATALOG # LN222515CT, LOT # 15230741L; SOUNDSTAR 10F-90 GE, CATALOG # SNDSTR10, LOT # UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CASE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE HAD DECREASED. ULTRASOUND WAS USED TO CONFIRM PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15214922M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R