BEUDAMED
    FDA Adverse Event Death Summary report: N

    THMCL SMARTTOUCH,TC,F,C3

    MDR report key: 7232886 · Received January 31, 2018

    Report

    Report Number
    2029046-2018-01123
    Event Type
    Death
    Date Received
    January 31, 2018
    Date of Event
    November 23, 2017
    Report Date
    January 12, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 30, 2017 ON THE EVENT. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION AND A CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR ATRIAL FLUTTER. THE AUTOPSY REVEALED A CARDIAC PERFORATION THAT WAS THOUGHT TO HAVE SELF-SEALED POST-PERICARDIOCENTESIS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE CARDIAC TAMPONADE IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION, AS THE PATIENT WAS ELDERLY AND FRAIL. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS RELATED TO THE TAMPONADE THAT RESULTED FROM THE SLOW PERICARDIAL EFFUSION. ALSO PROVIDED AN UPDATE THAT THE PRODUCT WAS DISPOSED OF. PER THE ADDITIONAL INFORMATION RECEIVED, UPDATED SEX, CONCLUSION CODES. AND DEVICE EVALUATED BY MANUFACTURER?. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. (B)(4).

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17714505M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES, US CATALOG #: CREFP6, LOT #: LL014927. STOCKERT GENERATOR, US CATALOG #: UNKNOWN, LOT #: UNKNOWN. CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, LOT #: UNKNOWN. COOLFLOW PUMP, US CATALOG #: UNKNOWN, LOT #: UNKNOWN. QUADRIPOLAR 5 FRENCH CATHETER, US CATALOG #: 37C03R, LOT: 17710479M. NON BIOSENSE WEBSTER, INC. - MERIT MEDICAL HEARTSPANTRANSSEPTAL NEEDLE, US CATALOG #: FND01901, LOT: Q1153145. PREFACE SHEATH, US CATALOG #: 301803M , LOT: 17664021 (X2) . LASSO NAVIGATIONAL CATHETER . US CATALOG #: D134301, LOT: 17710385L. HALO XP DEFLECTABLE CATHETER, US CATALOG #: 36J13R, LOT: 17614370L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION AND A CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR ATRIAL FLUTTER UNDER GENERAL ANESTHESIA WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND DEATH. PVI X 4 AND CTI WERE PERFORMED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). A FEW HOURS POST-PROCEDURE, THE PATIENT BECAME SIGNIFICANTLY HYPOTENSIVE AND WENT INTO CARDIAC ARREST. PATIENT WAS RESUSCITATED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ON POST-PROCEDURE DAY 1, THE PATIENT EXPIRED. THERE IS NO INFORMATION REGARDING THE CAUSE OF THE TAMPONADE. IT WAS NOTED THAT THE PHYSICIAN DOES NOT SUSPECT THAT THE TAMPONADE WAS PRODUCT-RELATED. AUTOPSY WAS NEGATIVE FOR CARDIAC TEARS AND PERFORATIONS. GENERATOR WAS SET ON TEMPERATURE CONTROL MODE. PVI ABLATION WAS PERFORMED ON THE ROOF, ANTERIOR WALL, AND RIDGE AT 35 WATTS WITH AN INDEX VALUE OF 500 AND ON THE INFERIOR AND POSTERIOR WALLS AT 25 WATTS WITH AN INDEX VALUE OF 380. CAVOTRICUSPID RIDGE ABLATION WAS PERFORMED AT 40 WATTS WITH INDEX VALUES RANGING FROM 400-550. IMPEDANCE RANGED FROM 160-220 OHMS. SINCE THIS ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76049 THMCL SMARTTOUCH,TC,F,C3 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17714505M 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R