BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 4242147 · Received November 11, 2014

    Report

    Report Number
    9673241-2014-00475
    Event Type
    Death
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE DEVICE HISTORY RECORD (DHR) 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. (B)(4). CONCOMITANT PRODUCTS: CARTO 3 SYSTEM MODEL #: M-4800-01 SERIAL#:(B)(4). STOCKERT GENERATOR MODEL #: UNKNOWN SERIAL#: UNKNOWN COOLFLOW PUMP MODEL #: UNKNOWN SERIAL #: UNKNOWN. PENTARAY CATHETER D128208 MODEL #: D-1282-08-S LOT#:17081943L0 PREFACE SHEATH MODEL #:301805M LOT#15684241 MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6)., MALE, UNDERWENT A ISCHEMIC VENTRICULAR TACHYCARDIA (VT) PROCEDURE WITH A THERMOCOOL SF NAVIGATIONAL CATHETER AND THE PATIENT DIED OF LACK OF PERFUSION DUE TO VENTRICULAR TACHYCARDIA (VT). CPR, SEVERAL DEFIBRILLATION SHOCKS AND ACLS MEASURES WERE TAKEN TO ATTEMPT TO SAVE THE PATIENT WITH NO SUCCESS. FOLLOW UP REVEALED THAT THE VT LED TO PULSELESS ELECTRICAL ACTIVITY (PEA). NO PROBLEMS WERE NOTED WITH ANY OF THE BWI DEVICES USED DURING THE PROCEDURE. THE PATIENT WAS ADMITTED FOR AN OCCLUDED RIGHT CORONARY ARTERY WHICH WAS STENTED ON (B)(6) 2014. THE PATIENT HAD A HISTORY OF VT, A BI-VENTRICULAR PACEMAKER AND DIABETES. THE PATIENT WAS ADMITTED IN STABLE CONDITION, IN A PACED RHYTHM. EPICARDIAL ACCESS WAS OBTAINED, AS WELL AS BILATERAL FEMORAL VENOUS ACCESS AND ARTERIAL ACCESS. EPICARDIAL ACCESS IS OFF LABEL USE OF BWI CATHETERS. THE PATIENT HAD ALLERGY TO AMIODARONE. INTRACARDIAC MAPPING WAS PERFORMED USING THE PENTARAY CATHETER TO OBTAIN VOLTAGE OF THE LEFT VENTRICLE (LV). THE VT WAS INDUCED AND SUSTAINED FOR A SHORT PERIOD OF TIME. THE PATIENT COULD NOT TOLERATE THE TACHYCARDIA AND WAS DEFIBRILLATED INTO A SINUS RHYTHM. PACE MAPPING WAS THEN ATTEMPTED AND INDUCED A VT. DEFIBRILLATION WAS ATTEMPTED, AND SHOCK WAS SUCCESSFULLY DELIVERED WITHOUT CARDIOVERSION TO SINUS RHYTHM. SEVERAL SHOCKS WERE ATTEMPTED AND ACLS PROTOCOL WAS INITIATED. CPR WAS ADMINISTERED. THE THERMOCOOL SF NAVIGATIONAL CATHETER WAS PULLED BACK INTO THE DESCENDING AORTA AT THE TIME WHEN THE PATIENT COULD NO LONGER BE CARDIOVERTED OUT OF VT TO NORMAL SINUS RHYTHM. NO ABLATIONS WERE DELIVERED FOR THIS PROCEDURE. PATIENT WAS NOTED TO BE IN PEA WITH NO PALPABLE PULSE. AFTER SEVERAL MINUTES OF ACLS THE PATIENT DID NOT RECOVER AND TREATMENT WAS WITHDRAWN. THE PHYSICIAN¿S OPINION WAS SUSTAINED VT LEADING TO PULSELESS ELECTRICAL ACTIVITY (PEA) AND HYPOPERFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725912 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-03-S 16045689L

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R