BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 6855728 · Received September 11, 2017

    Report

    Report Number
    2029046-2017-01007
    Event Type
    Death
    Date Received
    September 11, 2017
    Date of Event
    August 16, 2017
    Report Date
    August 21, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    Report Source
    Manufacturer report
    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 CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)). MANUFACTURER'S REF. NO: (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 SOUNDSTAR CATHETER AND EXPIRED ONE WEEK POST-PROCEDURE. MEDICAL HISTORY INCLUDES ISCHEMIC CARDIOMYOPATHY AND VT ABLATION PROCEDURES. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S UNDERLYING DISEASE STATE AND FAILURE TO THRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634149 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER SIMILAR DEVICE SNDSTR10, 510K # K070242 OBJ BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death