BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3885028 · Received June 19, 2014

    Report

    Report Number
    2029046-2014-00177
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. DEVICE HISTORY REPORT (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: REPROCESSED LASSO CATHETER; REPROCESSED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER; REPROCESSED CORONARY SINUS CATHETER; CARTO 3 SYSTEM; MODEL #: M-4800-01; SERIAL #: (B)(4). STOCKERT 70 SYSTEM; MODEL #: M-5463-01; SERIAL #: (B)(4). COOLFLOW PUMP MODEL #: M-5491-02 SERIAL #: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE ABLATION OF THE LEFT ATRIUM (LA) PULMONARY VEINS WAS COMPLETE AND THE PHYSICIAN WAS GETTING READY TO PULL ACROSS THE SEPTUM TO THE RIGHT ATRIUM (RA) WHEN THE ANESTHESIOLOGIST NOTICED THE PATIENT¿S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS NOTED ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. THE PROCEDURE WAS ABORTED. AT THE TIME OF THE CALL, A PERICARDIOCENTESIS WAS BEING PERFORMED AND THE PATIENT WAS STABLE. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY ADDITIONAL INTERVENTION WAS PERFORMED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361689 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1313-05-S UNKNOWN_D-1313-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R