BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 23888400 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49292
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    September 23, 2025
    Manufacturer
    ABIOMED, INC. -
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODE A040101 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER AND A0414 WAS ADDED TO REPLACE THAT CODE.

    Additional Manufacturer Narrative · 0

    DEVICE RECEIVED, INV IN PROGRESS: THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. DURING TRANSPORT TO THE CARDIAC CARE UNIT, THE HOSPITAL BED ACCIDENTALLY COLLIDED WITH THE AUTOMATED IMPELLA CONTROLLER (AIC), CAUSING THE WHITE PLUG ON THE DEVICE CABLE TO BREAK. PART OF THE PLUG REMAINED LODGED IN THE AIC CONNECTION PORT. THE PATIENT WAS IMMEDIATELY RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY, WHERE THE IMPELLA DEVICE WAS REMOVED. FOLLOWING DEVICE REMOVAL, OOZING WAS NOTED AT THE ACCESS SITE AFTER PERCLOSE CLOSURE. MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 20 MINUTES TO ACHIEVE HEMOSTASIS. TWO PERCLOSE PROGLIDE DEVICES HAD BEEN USED DURING THE PRE-CLOSE PROCEDURE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION, AND THE ACCESS SITE REMAINED STABLE. THE PATIENT¿S SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616303 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - IMPELLA CP 2026723852 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1