BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24639268 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05633
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    October 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER INVESTIGATOR CHANGED FROM PURGE CASSETTE TO PUMP. ¿NO PATIENT INVOLVEMENT¿ AND ¿NO PATIENT CONSEQUENCE¿ REMOVED. ¿DELAY TO TREATMENT/THERAPY¿ ADDED. D1, D4, H4, AND H6 HEALTH EFFECT - IMPACT CODE REVISED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AN 84 YEAR OLD FEMALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH A PERCUTANEOUS CORONARY INTERVENTION TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY EARLIER ON THE SAME DAY DEVELOPED DE NOVO CHEST PAIN AND ST SEGMENT ELEVATIONS, REQUIRING RE-EVALUATION IN THE CATHETERIZATION LABORATORY. PLACEMENT OF AN IMPELLA CP WAS PLANNED. WHILE IMPELLA WAS BEING PREPARED FOR PURGING AND CONNECTION TO THE CONTROLLER, DURING PREPARATION OF THE PURGE SOLUTION AND PURGE CASSETTE A "PURGE SYSTEM FAILURE" ALARM OCCURRED. PREPARATION WAS CONTINUED DESPITE THE ALARM AND THE ALARM EVENTUALLY DISAPPEARED DURING NEXT STEPS. THE IMPELLA WAS THEN DELIVERED INTO THE LEFT VENTRICLE BUT THE WIRE BECAME STUCK WHEN TRYING TO REMOVE IT FROM THE PUMP. THE SYSTEM IN ITS ENTIRETY WAS REMOVED WITHOUT CONSEQUENCES TO THE PATIENT AND THE IMPELLA WAS THEN REPLACED WITH A NEW CP THAT COULD BE DELIVERED WITHOUT ISSUES. THE PERCUTANEOUS INTERVENTION WAS CARRIED OUT AND THE NEW DEVICE WEANED AND REMOVED SUCCESSFULLY AFTER THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346943 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026716790 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1