BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 3430556 · Received October 25, 2013

    Report

    Report Number
    2029046-2013-00151
    Event Type
    Death
    Date Received
    October 25, 2013
    Date of Event
    July 15, 2013
    Report Date
    October 1, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OBJ
    PMA / PMN Number
    K070242
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    AFTER THE PROCEDURE, THE SOUNDSTAR 3-D ULTRASOUND CATHETER ENTRY POINT IN THE FEMORAL ARTERY DID NOT SEAL PROPERLY, THEY WERE NOT ABLE TO USE AN ANGIOSEAL (AN 8.5 FRENCH SHEATH ¿ NON BWI PRODUCT) SO IT WAS PERFORMED DOWN TO MANUAL PRESSURE. THE PATIENT BLEED AND DUE THE HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY CONDITION, IT WAS NOT CAPABLE TO HANDLE WITH REDUCED VOLUMES AND ARRESTED ALMOST IMMEDIATELY IN RECOVERY. EMERGENCY SURGERY BROUGHT AN OUTPUT BACK, BUT THERE HAD BEEN UNDERPERFUSION OF ORGANS BY THEN. THE PATIENT DIED TWO DAYS LATER. ON (B)(6), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THE PHYSICIAN OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548666 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER, INC (IRWINDALE) M-5723-12 UNKNOWN_M-5723-12

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death