BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER SOUNDSTAR 3D

    MDR report key: 4373591 · Received December 17, 2014

    Report

    Report Number
    4373591
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 16, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST WAS ATTEMPTING TO DO CARDIAC ABLATION FOR ATRIAL FIBRILLATION. TWO OF THE CATHETERS USED FOR THE PROCEDURE WERE DEFECTIVE. THE PRODUCT REP WAS IN THE ROOM FOR THE PROCEDURE AND TRIED TROUBLESHOOTING THE ECHO MACHINE FOR THE FIRST CATHETER. A SECOND CATHETER WAS OBTAINED AND IT TOO DID NOT WORK. A SECOND PRODUCT REP CAME TO ASSIST WITH TROUBLESHOOTING THIS CATHETER. A THIRD CATHETER WAS OBTAINED AND THAT ONE DID WORK. THEY WERE ABLE TO SUCCESSFULLY DO THE ABLATION. PLEASE NOTE THAT THESE WERE REPROCESSED CATHETERS THAT MALFUNCTIONED OR DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829240 BIOSENSE WEBSTER SOUNDSTAR 3D CATHETER, DIAGNOSTIC ULTRASOUND OBJ STRYKER SUSTAINABILITY SOLUTIONS SOUNDSTAR 3D 10F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR CARDIAC DRUGS