BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 24233110 · Received February 2, 2026

    Report

    Report Number
    2249723-2026-0001036
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    November 26, 2025
    Report Date
    February 17, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THERE WAS NO MALFUNCTION. THE ISSUE INVOLVED IS ONLY DIFFICULTY IN BALLOON INSERTION. THE PUMP WAS NOT AT ALL ACTIVE DURING THIS EVENT. THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE(2249723-2026-0001036).

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THERE WAS NO MALFUNCTION. THE ISSUE INVOLVED IS ONLY DIFFICULTY IN BALLOON INSERTION. THE PUMP WAS NOT AT ALL ACTIVE DURING THISEVENT. THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE(2249723-2026-0001036).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF AN INTRA-AORTIC BALLOON PUMP (IABP), THE PHYSICIAN ATTEMPTED TO INSERT A 50CC CATHETER USING THE PROVIDED 8FR SHEATH. THE CATHETER WAS ADVANCED APPROXIMATELY HALFWAY WHEN BLOOD REFLUX WAS OBSERVED AND THE BALLOON BEGAN TO UNRAVEL. THE SHEATH WAS THEN REPLACED WITH ANOTHER 8FR SHEATH (TERUMO BRAND), AND THE SAME CATHETER WAS REINSERTED; HOWEVER, THE ISSUE RECURRED WITH BALLOON UNRAVELLING DURING ADVANCEMENT. A NEW CATHETER WAS SUBSEQUENTLY USED WITH A 9FR SHEATH, AND THE INSERTION WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THE PHYSICIAN PERFORMING THE PROCEDURE IS EXPERIENCED IN IAB CATHETER INSERTIONS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291902 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SENSATION PLUS 50CC