BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA IABP

    MDR report key: 17940234 · Received October 13, 2023

    Report

    Report Number
    MW5146962
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 26, 2023
    Report Date
    October 10, 2023
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED AXILLARY PLANED IABP(INTRA-AORTIC BALLOON PUMP) ON (B)(6) 2023 RELATED TO WORSENING HEART FAILURE REQUIRING MECHANICAL CIRCULATORY SUPPORT. IABP WAS PLACED IN THE CATH(CATHETERIZATION) LAB. ON (B)(6) 2023, BEDSIDE RN NOTED ALARMS FROM CONSOLE RELATED TO INABILITY TO INFLATE BALLOON. RN NOTED BLOOD IN HELIUM TUBING REFLECTING RUPTURE OF THE IAB(INTRA-AORTIC BALLOON PUMP). PROVIDER WAS NOTIFIED AND IAB WAS PLACED IN "STANDY" UNTIL IT COULD BE REPLACED. IABP WAS REMOVED AND REPLACED WITH MICROAXIAL VENTRICULAR ASSIST DEVICE (IMPELLA). PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 DUE TO WORSENING HEART FAILURE, WAS PLACED ON HIGH DOSE INOTROPES WITH INVASIVE HEMODYNAMIC MONITORING AND WAS UPGRADED ON THE WAIT LIST FOR HEART TRANSPLANTATION. PATIENT'S HEMODYNAMIC STATUS AGAIN WORSENED REQUIRING IABP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312097 ULTRA IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP INSIGHTRA MEDICAL, INC. IMU7F-40

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| L