BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA 7.5FR. 40CC IAB

    MDR report key: 24105180 · Received January 17, 2026

    Report

    Report Number
    2248146-2026-0000356
    Event Type
    Malfunction
    Date Received
    January 17, 2026
    Date of Event
    January 13, 2024
    Report Date
    January 16, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107974
    PMA / PMN Number
    K120868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN BLOCK E1, EVENT SITE NAME: (B)(6). INTERFACE TROUBLESHOOTING CONFIRMED THAT THE ARTERIAL LINE WAVEFORM WAS BEING SOURCED FROM AN EXTERNAL BEDSIDE CABLE RATHER THAN THE IAB CENTRAL LUMEN. THE EXTERNAL A-LINE SETUP WAS EXPLAINED, AND THE USER CONFIRMED UNDERSTANDING.

    Description of Event or Problem · 0

    THE USER CONTACTED THE EMERGENCY SUPPORT PROGRAM LINE TO REPORT THAT THE PATIENT ARRIVED FROM THE CVOR WITH THE IAB CENTRAL LUMEN CLOTTED. DESPITE THIS, AN ARTERIAL LINE WAVEFORM WAS PRESENT ON THE PUMP. THE USER REQUESTED CLARIFICATION ON HOW AN A-LINE WAVEFORM COULD BE DISPLAYED WHEN THE IAB CENTRAL LUMEN IS CLOTTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166430 MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0295-01 10607567107974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARDIOSAVE