BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6294862 · Received February 1, 2017

    Report

    Report Number
    9673241-2017-00079
    Event Type
    Death
    Date Received
    February 1, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 13, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 8, 2017 STATED THAT THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION AFTER CARDIOGENIC SHOCK. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM V6; MODEL #: M-4800-01; SERIAL #: (B)(4). EP - SHUTTLE RF GENERATOR SYSTEM - 100W; MODEL #: 39D-76X; SERIAL #: (B)(4). COOLFLOW PUMP; MODEL #: M-5491-01; SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A NAVISTAR THERMOCOOL CATHETER AND PENTARAY CATHETER AND SUFFERED AN ACUTE MYOCARDIAL INFARCTION (REQUIRING A LEFT ANTERIOR DESCENDING CORONARY ARTERY STENT), CARDIOGENIC SHOCK (REQUIRING EXTRACORPOREAL MEMBRANE OXYGENATION AND SURGICAL INTERVENTION OF IMPELLA LEFT VENTRICULAR ASSIST DEVICE) AND THE PATIENT EXPIRED. DURING THE PROCEDURE, THE LEFT VENTRICLE WAS MAPPED WITH THE PENTARAY CATHETER. NAVISTAR THERMOCOOL CATHETER WAS CONNECTED, BUT NOT IN THE CHAMBER. VENTRICULAR TACHYCARDIA WAS SUCCESSFULLY INDUCED VIA PACING FROM THE RIGHT VENTRICLE. CARDIOVERSION FAILED TO CONVERT THE ARRHYTHMIA AND THE PATIENT DECOMPENSATED AND REQUIRED RESUSCITATION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT REMAINED IN THE INTENSIVE CARE UNIT AT THE TIME OF COMPLAINT UPDATE. PATIENT OUTCOME WAS UNCHANGED. IT WAS NOTED THAT THE ADVERSE EVENTS WERE NOT RELATED TO BIOSENSE WEBSTER, INC. PRODUCTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENTS IS THAT THEY WERE PATIENT CONDITION RELATED AND NOT RELATED TO THE CARTO 3 SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 26, 2016 THAT THE PATIENT EXPIRED. WE ARE ATTEMPTING TO OBTAIN CLARIFICATION. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT RESULTED IN THE PATIENT'S DEATH, IT IS TO BE CONSIDERED MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76572 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S UNKNOWN_D-1197-16-S JRZ

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R