BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 2063503 · Received April 19, 2011

    Report

    Report Number
    9673241-2011-00033
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO XP SYSTEM: MODEL #: M-4700-01, SERIAL #: (B)(4). COOL FLOW IRRIGATION PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4). STOCKERT RF GENERATOR: MODEL #:M-5463-01, SERIAL #: (B)(4). THE CUSTOMER (LAB (B)(4)) WAS CONTACTED BY BIOSENSE WEBSTER FIELD SERVICE ENGINEER. THE LAB (B)(4) ADVISED THAT THE PATIENT INJURY WAS NOT RELATED TO ANY FAILURE OF A BWI PRODUCT. THE CUSTOMER DECLINED SYSTEM SERVICE AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED CATHETER WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, GENERATOR TEST, PATENCY TEST. THE ELECTRICAL LEAKAGE AND RESISTANCE PASSED SPECIFICATION. THE THERMOCOUPLE SENSOR PERFORMED TO SPECIFICATION WHEN IMMERSED IN FLUID WITH CONTROLLED TEMPERATURE. THE CATHETER INTERFACED WITH THE STOCKERT GENERATOR OBTAINING ACCEPTABLE RESULTS. THE CATHETER FAILED PATENCY FLOW TEST SINCE IT WAS NOT IRRIGATING FROM TWO TIP DOME HOLES; THE OTHER FOUR WERE IRRIGATING FINE. STEAM POPS ARE GENERALLY ASSOCIATED WITH EXCESSIVE RF ENERGY APPLICATION. EXCESSIVE RF ENERGY DELIVERY CAN BE CAUSED BY A RAPID POWER RAMPING OR EXTENDED RF APPLICATION TO A SINGLE AREA OR BY FAILING TO PROPERLY LIMIT POWER DELIVERY FOR THE TARGET TISSUE. THE CAUSE OF THE REPORTED EVENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SIDE A-FLUTTER PROCEDURE, A STEAM POP WAS HEARD AND THE PATIENT'S BLOOD DROPPED. THE PATIENT WAS THEN PREPPED FOR PERICARDIOCENTESIS AND MEDICATION WERE GIVEN TO INCREASE BLOOD PRESSURE. ONCE PATIENT WAS STABILIZED, HE WAS TRANSFERRED TO ICU. ADDITIONAL INFORMATION PROVIDED STATED THAT AT THE TIME THE COMPLAINT WAS REPORTED, IT LOOKED LIKE THE PERICARDIOCENTESIS WAS SUFFICIENT. HOWEVER, BECAUSE, THE PATIENT CONTINUE TO BLEED, LATER ON THE PHYSICIAN PERFORMED A SURGERY TO REPAIR THE PERFORATION. PATIENT HAS NOW BEEN RELEASED, PROGNOSIS WAS GOOD. THERE WAS NO LONG TERM EFFECT TO THE PATIENT. THE PHYSICIAN STATED THAT THERE WAS NO MALFUNCTION TO ANY OF BWI PRODUCTS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15328326M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R