BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION 7FR. 40CC IAB

    MDR report key: 23967636 · Received January 5, 2026

    Report

    Report Number
    2248146-2026-0000076
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    May 3, 2024
    Report Date
    January 5, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567106779
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT SITE NAE IS (B)(6). THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS RETAINED BY USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT RECORD ID # (B)(4).

    Description of Event or Problem · 0

    USER CALLED INTO EMERGENCY SUPPORT PROGRAM (ESP) LINE TO REQUEST SUPPORT WITHA CATHETER RESTRICTION ALARM. USER TROUBLESHOOTED BUT WITHUT SUCCESS AND ALSO MARKER WAS NOT VISIBLE IN THE CHEST X-RAY TAKEN. THE ESP PERSONEL HAD REVIEWED AND DISCUSSED THE TROUBLESHOOTING STEPS TO THE USER IN DETAIL. USER STATED THAT AFTER SOME TIME, SURGEON WAS ABLE TO REPOSITION THE CATHETER EFFECTIVELY AND THE PUMP IS NOW WORKING WELL.NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27854 SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0470-01 10607567106779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARDIOSAVE.