BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 6233931 · Received January 9, 2017

    Report

    Report Number
    2029046-2017-00012
    Event Type
    Death
    Date Received
    January 9, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OBJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SR0 8.5 FRENCH SHEATH. (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, BIOSENSE WEBSTER, INC. REPORTED THIS EVENT UNDER BOTH THE EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER (9673241-2017-00038) AND THE SOUNDSTAR CATHETER (2029046-2017-00012). HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON JANUARY 20, 2017 STATING THAT THE SOUNDSTAR CATHETER WAS REPROCESSED BY (B)(4) WHICH IS A DISTRIBUTED PRODUCT. THE MODEL NUMBER IS M-5723-116. THE LOT NUMBER IS UNKNOWN. THEREFORE, THIS PRODUCT IS NOT REPORTABLE UNDER BIOSENSE WEBSTER, INC. NOTIFICATION HAS BEEN PROVIDED TO (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT IN HIS 70S UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PHARMACOLOGIC SUPPORT) WHICH RESULTED IN DEATH. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND EXPIRED THE SAME DAY. CARDIOVASCULAR MEDICAL HISTORY INCLUDES: ISCHEMIC CARDIOMYOPATHY WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 15%, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND TOTAL OCCLUSION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH STENTS IN THE LEFT CIRCUMFLEX (LCX) AND THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERIES. THERE WERE NO OTHER FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MAY HAVE BEEN RELATED TO THE SOUNDSTAR CATHETER BEING IN THE RIGHT ATRIUM DURING CARDIOVERSION OF VENTRICULAR TACHYCARDIA (8 SHOCKS). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED, AS THE PHYSICIAN USED A RETROGRADE AORTIC APPROACH. SHEATH USED WAS A ST. JUDE MEDICAL SR0 8.5 FRENCH. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED POWER CONTROL MODE AT 30 WATTS (NOT TITRATED). ONE ABLATION WAS PERFORMED FOR 3 SECONDS ON THE VENTRICULAR SEPTUM. IRRIGATED CATHETER FLOW WAS SET AT 8 ML/MIN. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED IN AN UNKNOWN RANGE. THERE WERE NO REPORTS OF SOUNDSTAR ISSUES OR MALFUNCTIONS WITH IMAGING OR MAPPING. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. 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
    15875 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER SIMILAR DEVICE SNDSTR10, 510K # K070242 OBJ BIOSENSE WEBSTER, INC. (IRWINDALE) M-5723-00 OEM_M-5723-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R