BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER NAVIGATIONAL 8MM (DS)

    MDR report key: 2113767 · Received June 3, 2011

    Report

    Report Number
    2029046-2011-00043
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED. BWI FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER TO SCHEDULE EVALUATION OF BWI SYSTEM DEVICES . CUSTOMER DECLINED SERVICE, SYSTEM IS WORKING AND READY TO BE USE. BWI CONCOMITANT PRODUCTS: STOCKERT 70 RF GENERATOR: US CAT NUM: S7001, (B)(4). COOLFLOW IRRIGATION PUMP: US CAT NUM: CFP002, (B)(4). CARTO XP SYSTEM: US CAT NUM: M470001, (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER GAINING ACCESS TO THE LEFT ATRIUM VIA TRANSSEPTAL PROCEDURE, PHYSICIAN NOTICED THAT DOUBLE SHADOWS WERE APPEARING ON FLUOROSCOPY. STAT ECHO WAS ORDERED AND CARDIAC SURGERY WAS CALLED FOR CONSULTATION. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AFTER TAMPONADE/EFFUSION WAS CONFIRMED. PERICARDIAL SYNTHESIS WAS PERFORMED AND FLUID WAS REMOVED FROM THE PERICARDIAL SACK. PATIENT HAS RECOVERED. PATIENT PROGNOSIS WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER NAVIGATIONAL 8MM (DS) CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) EZ STEER NAVI 8MM (DS) UNK_EZ STEER NAVI 8MM (DS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R