BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2250447 · Received September 15, 2011

    Report

    Report Number
    9673241-2011-00095
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 29, 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

    (B)(4). THE CATHETER WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, GENERATOR TEST, PATENCY AND FLOW RATE TEST, DEFLECTION TEST AND FOR VISUAL CHARACTERISTICS INSPECTION. 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 RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS LIFE THREATENING AND THE DAMAGE TO HEART WERE MODERATE. PHYSICIAN/CUSTOMER'S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE-RELATED. THE CONCOMITANT DEVICES: CARTO 3 SYSTEM, US CATALOG #: FG540000, (B)(4); STOCKERT 70 SYSTEM, US CATALOG #: S7001, (B)(4); COOL FLOW PUMP, U.S. SHIP KIT, US CATALOG #: CFP002, (B)(4). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SIDED ATRIAL TACHYCARDIA, THE PATIENT EXPERIENCED A TAMPONADE. THE PATIENT'S BLOOD PRESSURE DECREASED AND A PERICARDIOCENTESIS WAS PERFORMED EXTRACTING 300 CC OF FLUID. THE PATIENT WAS GIVEN UNKNOWN MEDICATIONS, THEN STABILIZED AND RETURNED TO THE HOLDING ROOM. THE DRAIN WAS LEFT IN OVERNIGHT AND THE PATIENT WAS DISCHARGED THREE DAYS LATER. THE FOLLOWING BWI PRODUCTS WERE INVOLVED CARTO 3, STOCKERT, COOL FLOW PUMP, NAVISTAR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15393107M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R