BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5981089 · Received September 27, 2016

    Report

    Report Number
    9673241-2016-00617
    Event Type
    Death
    Date Received
    September 27, 2016
    Date of Event
    September 30, 2015
    Report Date
    August 31, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO MAPPING SYSTEM. (B)(4). EVALUATION METHODS: NO TESTING METHODS PERFORMED; (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; (B)(4). CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP; (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 41 PATIENTS WITH STRUCTURAL HEART DISEASE UNDERGOING VT ABLATION USING THE CARTO UNIVU MODULE. ONLY 1 PROCEDURE-RELATED MAJOR COMPLICATION OCCURRED IN 1 PATIENT WHO DEVELOPED CARDIOGENIC SHOCK AFTER THE ABLATION PROCEDURE. INTRAVENOUS INOTROPES WERE STARTED WITHOUT POSITIVE RESPONSE, AND THE PATIENT UNDERWENT IMPLANTATION OF AN EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. FIVE DAYS AFTER THE ABLATION PROCEDURE, THE PATIENT FINALLY DIED WITH REFRACTORY CARDIOGENIC SHOCK. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WHO DIED WAS DUE TO ITS PREVIOUS CONDITIONS: ELECTRICAL STORM AND HEART FAILURE. THE PROCEDURE WENT WELL, AND THE DOCTOR ASSESSES THAT THE DEATH WAS NOT RELATED WITH ANY OF BWII PRODUCTS OR THE PROCEDURE ITSELF. TITLE: ¿SAFETY AND FEASIBILITY OF A MINIMALLY FLUOROSCOPIC APPROACH FOR VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WITH STRUCTURAL HEART DISEASE.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND FEASIBILITY OF A MINIMALLY FLUOROSCOPIC APPROACH USING THE CARTO UNIVU MODULE DURING SCAR-RELATED VENTRICULAR TACHYCARDIA (VT) ABLATION. THE STUDY WAS CONDUCTED FROM APRIL 2014 TO SEPTEMBER 2015. SUSPECTED DEVICE IS THERMOCOOL SMARTTOUCH ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633439 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| R