BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3102546 · Received May 9, 2013

    Report

    Report Number
    9673241-2013-00150
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    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

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: STOCKERT 70 SYSTEM: MODEL #:M-5463-01, SERIAL #: (B)(4). CARTO 3 SYSTEM: MODEL #:M-4800-01, SERIAL #: (B)(4). COOLFLOW PUMP: MODEL #:M-5491-02, SERIAL #: (B)(4). LASSO NAVIGATIONAL VARIABLE ECO CATHETER: MODEL #:D-1343-02-S, LOT #: 15797615L. DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE, A STEAM POP WAS HEARD. ABLATION WAS BEING DELIVERED IN THE LEFT ATRIUM AT 40 WATTS. THE ABLATION WAS TURNED OFF QUICKLY. THE ABLATION DATA GRAPH REFLECTED A RISE IN IMPEDANCE AT THE TIME OF THE POP. A PERICARDIAL EFFUSION WAS NOTED VIA ULTRASOUND. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABILIZED AND WAS ADMITTED FOR OBSERVATION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THE HIGH POWER AND CONTACT. THERE WAS SOME DIFFICULTY REACHING THE ANTERIOR RIGHT VEINS. THERE WAS ABOUT 80 ABLATION APPLICATIONS DELIVERED TO THE PATIENT BEFORE THE EVENT. THE RF GENERATOR WAS SET TO "POWER-CONTROL" MODE AT 42 WATTS. THE TEMPERATURE CUT OFF SETTING WAS SET TO 42 DEGREES AND THE FLOW SETTING 30ML/MIN. THE ACT WAS MAINTAINED BETWEEN 300-350'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203111 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15802519M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R