BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3230583 · Received July 16, 2013

    Report

    Report Number
    2029046-2013-00090
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCT: LASSO SAS; MODEL #: D-1312-01-S; LOT #: UNKNOWN_D-1312-01-S. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON THE EVENT. THE PHYSICIAN STATED THAT THEY INVESTIGATED THIS EVENT. THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK. THE BASELINE WAS SEVERE LEFT VENTRICULAR DYSFUNCTION AND VT STORM IN A (B)(6) MALE PATIENT. TAMPONADE WAS EXCLUDED BY ECHOCARDIOGRAPHY. THERE WAS NO EVIDENCE OF PRODUCT MALFUNCTION. NO EVIDENCE THAT A DEVICE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING APPROXIMATELY 30 MINUTES INTO THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. IT WAS DECIDED TO STOP THE PROCEDURE AT THIS POINT AND TO REMOVE THE CATHETERS FROM THE PATIENT. THE PATIENT¿S BLOOD PRESSURE CONTINUED TO DROP. THERE WAS NO CARDIAC OUTPUT. RESUSCITATION COMMENCED AND THEY CONTINUED TO ATTEMPT TO RESUSCITATE THE PATIENT FOR 15 MINUTES, HOWEVER, THE PATIENT DIED. THE PATIENT HAD A DEFIBRILLATOR IN SITU. THE PATIENT'S BLOOD PRESSURE WAS KNOWN TO BE LOW PRIOR TO PROCEDURE. THE EJECTION FRACTION WAS AROUND 20% BEFORE THE PROCEDURE, THEREFORE COMPROMISED THE CARDIAC FUNCTION PRIOR TO THE PROCEDURE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. APPROXIMATELY 30 MINUTES INTO THE VENTRICULAR TACHYCARDIA PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PATIENT¿S BLOOD PRESSURE WAS LOW TO BEGIN WITH AFTER THE ANESTHETIC STARTED. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE JUST A FEW MINUTES AFTER THE ABLATION STARTED. THE PHYSICIAN REMOVED THE CATHETERS FROM THE PATIENT. THE PATIENT¿S BLOOD PRESSURE CONTINUED TO DROP. THERE WAS NO CARDIAC OUTPUT. RESUSCITATION COMMENCED AND THE RESUSCITATION TEAM WAS CALLED IN. CPR WAS PERFORMED. THEY CONTINUED THE RESUSCITATION FOR 15-20 MINUTES, HOWEVER, THE PATIENT PASSED AWAY. THE PATIENT HAD A DEFIBRILLATOR IN SITU AT THE TIME OF THE EVENT. THE CAUSALITY OF THE ADVERSE EVENT WAS UNRELATED TO THE PROCEDURE OR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330012 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 Death| R