BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3060170 · Received April 16, 2013

    Report

    Report Number
    9673241-2013-00103
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 21, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CONCOMITANT PRODUCTS: CARTO 3 MODEL # M-4800-01, SERIAL # (B)(4); STOCKERT MODEL# M-5463-01 SERIAL # (B)(4); COOLFLOW PUMP MODEL# M-5491-02 SERIAL # (B)(4); CORONARY SINUS CATHETER, MODEL# UNKNOWN, LOT # UNKNOWN- CUSTOMER DISPOSED OF. LASSO NAV VARIABLE ECO, MODEL# D-1343-01-S, LOT # UNKNOWN- CUSTOMER DISPOSED OF. MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB CASE, THE PHYSICIAN NOTED A RISE IN TEMPERATURE ON THE THERMOCOOL CATHETER. THE TEMPERATURE LIMIT SETTING ON THE STOCKERT GENERATOR WAS REACHED. THE GENERATOR WAS SET TO THERMOCOOL SF SETTINGS AND THIS MUST HAVE BEEN 40 DEGREES. THE COOL FLOW PUMP SETTINGS WERE INITIALLY SET FOR THE THERMOCOOL SF (LOWER FLOW RATE) AND THEN CHANGED TO THE THERMOCOOL SETTINGS (HIGHER FLOW RATE) AFTER THE DISCREPANCY WAS NOTICED. THE FLOW SETTING ON THE COOL FLOW PUMP WAS AT 8ML. THE CATHETER WAS REMOVED, INSPECTED, AND THE PROCEDURE CONTINUED WITH THE SAME CATHETER AT A FLOW RATE OF 17 ML OR 30 ML. THERE WASN'T ANY CHAR STUCK ON THE CATHETER. AFTER THE PATIENT HAD BEEN RE-SEDATED IN THE RECOVERY ROOM, A STROKE WAS NOTED AND THE PATIENT WAS NOT ABLE TO SPEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162314 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15784124M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening