BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5651265 · Received May 12, 2016

    Report

    Report Number
    2029046-2016-00045
    Event Type
    Death
    Date Received
    May 12, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 20, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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: PENTARAY CATHETER (MODEL# UNKNOWN SERIAL # UNKNOWN). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WITH A THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER AND SUFFERED CARDIAC ARREST REQUIRING RESUSCITATION, CARDIOGENIC SHOCK REQUIRING AN ASSIST DEVICE, AND DEATH. AFTER ABLATION, THE PATIENT HAD INCESSANT VTS AND BECAME HEMODYNAMICALLY UNSTABLE. THE PATIENT WENT INTO CARDIAC ARREST WHICH REQUIRED DEFIBRILLATION AND CARDIAC MASSAGE WHICH WAS INEFFICIENT. THE PATIENT ALSO RECEIVED A VENTRICULAR ASSIST DEVICE TO SUPPORT THE HEART EJECTION RATE. PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IMMEDIATELY FOLLOWING THE EVENT. ON (B)(6) 2016, THE PATIENT EXPIRED DUE TO DAMAGE OF THE MYOCARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305662 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1347-00 UNKNOWN_D-1347-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death