BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8414961 · Received March 12, 2019

    Report

    Report Number
    2029046-2019-02793
    Event Type
    Death
    Date Received
    March 12, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 14, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: LASSO NAV 2515,22P SPLITHANDLE (MODEL#D-1343-01-S, LOT#UNKNOWN); CARTO3 EXTERNAL REF PATCH 6PACK (MODEL#D-1283-02, LOT#LL018062); CARTO 3 SYSTEM (MODEL#M-4800-01, SERIAL (B)(4)). MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH HISTORY OF ISCHEMIC, HYPERTROPHIC AND RHYTHMIC CARDIOMYOPATHY, LEFT VENTRICLE EJECTION FRACTION (LVEF) OF 35%, VASCULAR DISEASE (AORTIC THROMBOSIS) AND BRONCHO-PNEUMOPATHIE CHRONIC OBSTRUCTIVE (BPCO) PULMONARY DISEASE, UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND SUFFERED DEATH. ON (B)(6) 2019, THE PATIENT UNDERWENT A SUCCESSFUL ABLATION PROCEDURE WITH NO IMMEDIATE PATIENT CONSEQUENCES. NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS WERE REPORTED. POST-PROCEDURE, THE PATIENT DEVELOPED CHEST PAIN. ON POST-PROCEDURE DAY 2, TRANSTHORACIC ECHO (TEE) WAS PERFORMED AND WAS REPORTED TO GIVE NORMAL RESULTS, CHEST PAIN SPONTANEOUSLY STOPPED, AND THE PATIENT WAS DISCHARGED. ON POST-PROCEDURE DAY 5, THE PATIENT SUDDENLY DIED. PHYSICIAN¿S OPINION REGARDING CAUSE OF DEATH WAS THAT IT WAS INDEPENDENT OF BWI PRODUCT USE. THE PHYSICIAN DOES NOT MAKE A LINK BETWEEN THE DEATH AND USING BWI PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206244 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death