BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2200180 · Received August 10, 2011

    Report

    Report Number
    9673241-2011-00083
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS LIFE THREATENING, DURING A PROCEDURE TO TREAT ATRIAL FIB WITH RF, A MODERATE AMOUNT OF FLUID WAS NOTED ON THE ICE IMAGE TO BE PRESENT IN THE PERICARDIUM AND NEEDED THE SURGICAL INTERVENTION WHICH INCLUDED A PARACENTESIS, BLOOD TRANSFUSIONS AND SURGERY AND ALSO THE PATIENT REQUIRED HOSPITALIZATION. FOLLOW UP WITH (B)(4) FOUND THE PATIENT DOING WELL AND THE PROGNOSIS FOR THE PATIENT WAS SATISFACTORY. CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE RELATED. THE FACILITY DID NOT PROVIDE FURTHER INFORMATION REGARDING THE PATIENT OR THE PROCEDURE. IF THE SINGLE USE PRODUCTS ARE RETURNED TO BWI, AN INVESTIGATION WILL BE PERFORMED AND A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THE CONCOMITANT DEVICES: LASSO 2515 NAV VARIABLE CATHETER, US CATALOG #: LN122515CT, LOT # 15341813L; SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER 10F, US CATALOG #: SNDSTR10, LOT # 10036558; WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID, US CATALOG #: D610DRP10CT, LOT # 15083440; PREFACE GUIDING SHEATH WITH MULTIPURPOSE-SHORT CURVE, US CATALOG #: 301803MS, LOT # 15249227; HEARTSPAN TRANSSEPTAL NEEDLE & STYLET KIT, US CATALOG #: FND01902, LOT # S34241; COOLFLOW IRRIGATION PUMP, US CATALOG #: CFP002 , (B)(4); STOCKERT 70 RF GENERATOR, US CATALOG #: S7001 , (B)(4); CARTO 3 SYSTEM, US CATALOG #: FG540000 , (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE HAVING AN AFIB PROCEDURE PERFORMED THE PATIENT SUFFERED A PERFORATION IN THE LEFT ATRIUM OF THE HEART. THE PATIENT HAD A PERICARDIOCENTESIS PERFORMED AND WAS GIVEN MULTIPLE UNITS OF BLOOD. THE PATIENT WAS IN TRANSIT TO THE OPERATING ROOM AT THE TIME THIS EVENT WAS BEING CALLED IN. THERE WAS NO MALFUNCTION WITH ANY EQUIPMENT NOTED AND NO ERROR MESSAGES REPORTED. IN USE WERE THE FOLLOWING BWI ITEMS: CARTO3, STOCKERT, COOL FLOW PUMP, 2 PREFACE SHEATHS (DISPOSED OF), AND A HEARTSPAN NEEDLE (DISPOSED OF).

    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 15390670M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R