BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23896766 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49277
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 26, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ==> NO PRODUCT WAS RETURNED. UNABLE TO DELIVER OR ADVANCE (DELIVERY ISSUE): THE CAUSE OF THE DELIVER ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD DIFFICULT ANATOMY ALONG WITH RESISTANCE IN FEMORAL ARTERY PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT ==> DEVICE LOT: 1951048 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW ==> DEVICE (SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS ATTEMPTED TO BE IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING A PIGTAIL CATHETER INTO THE LEFT VENTRICLE, WHICH WAS EVENTUALLY SUCCESSFUL. HOWEVER, THE IMPELLA CP COULD NOT BE ADVANCED THROUGH THE ILIAC ARTERY DUE TO CHALLENGING ANATOMY. MULTIPLE ATTEMPTS WITH VARIOUS WIRES WERE UNSUCCESSFUL, AND IMPELLA CP PLACEMENT WAS ULTIMATELY ABORTED DUE TO THE PATIENT¿S ANATOMICAL LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330296 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026701204 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male