BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION 7FR. 40CC IAB CATHETER

    MDR report key: 2973842 · Received February 13, 2013

    Report

    Report Number
    MW5029023
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MAQUET
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IABP ALARMING FOR CATHETER MALFUNCTION. UNABLE TO TROUBLESHOOT AND CORRECT PROBLEM. CATHETER LODGED AND WOULD NOT COME OUT. CATHETER WAS REMOVED WITH USE OF FORCEPS AFTER INCISION MADE AT INSERTION SITE. CLOT NOTED INSIDE SHEATH OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64421 SENSATION 7FR. 40CC IAB CATHETER IABP DSP MAQUET 2840

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention