BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECP PUMP SET

    MDR report key: 24208195 · Received January 29, 2026

    Report

    Report Number
    1220648-2026-01815
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT FOR 1220648-2026-01815 WAS FILED IN ERROR.

    Description of Event or Problem · 0

    A 57-YEAR-OLD MALE PATIENT UNDERWENT A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) PROCEDURE. DURING THE ECP RESEARCH CASE, MID-PCI, A RED ¿AIR IN PURGE SYSTEM¿ ALARM APPEARED ON THE CONSOLE. THE ECP TEAM ADVISED REPLACING THE PUMP ENTIRELY. THE PHYSICIAN WAS INFORMED AND PROCEEDED AS RECOMMENDED. PUMP 1 (MODEL: CP, SERIAL NUMBER: (B)(6), (B)(4), GU CASE (B)(4) WAS IMPLANTED VIA RIGHT FEMORAL ARTERIAL ACCESS AT 10:53 AM ON (B)(6) 2026 AND EXPLANTED AT 11:40 AM THE SAME DAY. THE PATIENT REMAINED STABLE AND SURVIVED THE PROCEDURE. THE DEVICE WAS SUCCESSFULLY EXPLANTED, AND NO ADVERSE PATIENT OUTCOME WAS REPORTED. INVESTIGATION WILL FOCUS ON THE PRIMING ISSUE AND IS PENDING AT THE TIME OF THIS REPORT. THE IMPELLA CP WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567167 ECP PUMP SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026799462

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention