BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 24090546 · Received January 15, 2026

    Report

    Report Number
    2248146-2026-0000326
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    June 5, 2024
    Report Date
    January 16, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATIONS IN E1 EVENT SITE NAME - (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4).

    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 INNER LUMEN IS UNABLE TO BE ASPIRATED ISSUE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151429 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARDIOSAVE