BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3070676 · Received April 22, 2013

    Report

    Report Number
    2029046-2013-00051
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4). COOL FLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). LASSO CATHETER, MODEL #: UNK, LOT #: UNK. SOUNDSTAR CATHETER, MODEL #: M-5723-00, LOT #: UNK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. IT WAS STATED BY THE CUSTOMER THAT THE PRODUCT HAD BEEN DISCARDED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY. THE ANTICOAGULANT HEPARIN WAS REVERSED BY ADMINISTERING PROTAMINE. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 400 ML OF FLUID WERE REMOVED. THE PATIENT WAS INTUBATED AND IN STABLE CONDITION. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN FELT THE PERFORATION OCCURRED DURING THE TRANSSEPTAL NEEDLE STICK (NON-BWI PRODUCT). IT WAS UPDATED THE PATIENT WAS DOING FINE AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171895 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-06-S UNKNOWN_D-1317-06-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R