BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTARAY NAV

    MDR report key: 7134286 · Received December 20, 2017

    Report

    Report Number
    2029046-2017-01293
    Event Type
    Death
    Date Received
    December 20, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 23, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: UNSPECIFIED WEBSTER CS CATHETER. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WITH A PENTARAY NAV ECO CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING DEFIBRILLATION, CARDIOPULMONARY RESUSCITATION, AND SURGICAL INTERVENTION) AND DEATH. DURING THE PROCEDURE, WHEN THE PENTARAY CATHETER WAS INTRODUCED INTO THE RIGHT VENTRICLE, MECHANICAL INDUCTION OF FAST VENTRICULAR TACHYCARDIA OCCURRED. PATIENT WAS DEFIBRILLATED MULTIPLE TIMES, CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED, AND AN IMPELLA EXTERNAL HEART ASSIST DEVICE WAS PLACED. PATIENT STABILIZED AFTER 25 MINUTES. AT AN UNSPECIFIED POINT, THE IMPELLA WAS EXPLANTED. PATIENT WAS HOSPITALIZED 2 WEEKS PRE-PROCEDURE AND EXPIRED 2 DAYS POST-PROCEDURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION. IT WAS NOTED THAT THE DEATH MAY HAVE BEEN RELATED TO THE PATIENT¿S LOW EJECTION FRACTION AND IMPELLA EXPLANTATION. NO AUTOPSY REPORT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914995 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| R