BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1976099 · Received February 1, 2011

    Report

    Report Number
    9673241-2011-00014
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER WAS TESTED AND PASSED PATENCY/FLOW, DEFLECTION, ELECTRICAL, TEMPERATURE AND GENERATOR TEST. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    A 3500A SUPPLEMENTAL WILL BE SUBMITTED ONCE THE ANALYSIS IS COMPLETED. CONCOMITANT PRODUCTS: STOCKERT 70 RF GENERATOR; US CAT NUM S7001, SERIAL NUMBER (B)(4). COOLFLOW IRRIGATION PUMP; US CAT NUM CFP002, SERIAL NUMBER (B)(4). CARTO 3 SYSTEM; US CAT NUM FG540000, SERIAL NUMBER (B)(4). WEBSTER DUO-DECAPOLAR; US CAT NUM D728260RT, LOT NUMBER: UNKNOWN. LASSO 2515 NAV VARIABLE CATHETER; US CAT NUM LN222515CT, LOT NUMBER: 15270825L. SOUNDSTAR 3D 10F-90; US CAT NUM SNDSTR10, LOT NUMBER: UNKNOWN. CUSTOMER DECLINED SERVICE ON STOCKERT AND COOL FLOW PUMP. HOWEVER, AS A PREVENTIVE MAINTENANCE, BWI FIELD SERVICE ENGINEER PERFORMED AN INITIAL INSPECTION ON THE CARTO 3 SYSTEM. BASED ON THE INITIAL INSPECTION AND TESTING, ALL TESTING PASSED. NOISE EXPERIENCED ON THE PROCEDURE MAY HAVE ATTRIBUTED TO THE FAULTY LASSO CATHETER THAT COULD ONLY FAM AND NOT VISUALIZE. CARTO 3 SYSTEM WAS USED THE NEXT DAY FOR ANOTHER PROCEDURE AND ABSOLUTELY NO NOISE WAS OBSERVED ON ANY CHANNELS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER LEFT SIDE PROCEDURE, THE PHYSICIAN PROCEEDED TO ABLATE WITH A CATHETER AT 50W 30ML. THE PHYSICIAN HEARD AND FELT A STEAM POP ON THE FIRST ABLATION. APPROXIMATELY TEN MINUTES LATER, THE PATIENT SPONTANEOUSLY WENT INTO A SINUS RHYTHM AND THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. PACING WAS STARTED TO INCREASE THE PATIENT'S HEART RATE BUT THE BLOOD PRESSURE CONTINUES TO DROP. PHYSICIAN EVALUATED THE VENTRICLE BY ICE AND DISCOVERED AN EFFUSION. PERICARDIOCENTESIS WAS PERFORMED TO CORRECT THE EFFUSION AND DRAINED OFF BLOOD FROM THE PERICARDIUM. CASE WAS ABANDONED. IT WAS ALSO NOTED THAT THERE WAS NOISE ON CARTO 3 SYSTEM THROUGHOUT THE PROCEDURE. PATIENT HAS FULLY RECOVERED AND PATIENT PROGNOSIS WAS SATISFACTORY. CAUSALITY OF THE ADVERSE EVENT IS POSSIBLE PROCEDURE RELATED.

    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 15270903M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R