BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 24144284 · Received January 22, 2026

    Report

    Report Number
    2248146-2026-0000503
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    May 28, 2024
    Report Date
    January 22, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME-(B)(6). PATIENT HAD A NON-FO IAB CATHETER AND THE INNER LUMEN IS UNABLE TO BE ASPIRATED AND CLOTTED OFF. ESP PERSONNEL STATE THAT THEY DO NOT RECOMMEND ANY MEDICATIONS BE USED TO CLEAR A CLOTTED LINE AND AN ALTERNATE AP SOURCE SHOULD BE SOUGHT.

    Description of Event or Problem · 0

    USER CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST AND REPORT ISSUE DURING USE INTRA AORTIC BALLOON (IAB) HAD CLOTTED INNER LUMEN AND UNABLE TO BE ASPIRATED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203895 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARDIOSAVE