BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 19070462 · Received April 9, 2024

    Report

    Report Number
    1220648-2024-09621
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    May 22, 2022
    Report Date
    April 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011531
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW. DUE TO THE LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT THE ROOT CAUSE OF THIS INVESTIGATION IS NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE,¿AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿DO NOT CLEAN WITH OR EXPOSE ANY PART OF THE CLEAR SIDEARM OF THE IMPELLA CATHETER (E.G., INFUSION FILTER, PRESSURE RESERVOIR) TO ALCOHOL. ALCOHOL HAS BEEN SHOWN TO CAUSE CRACKS AND LEAKS IN THESE COMPONENTS. CAREFULLY READ LABELS ON COMMON SKIN PREPS AND LOTIONS TO AVOID USING ANY ALCOHOL-CONTAINING PRODUCTS IN THE AREA OF THE INFUSION FILTER OR PRESSURE RESERVOIR." ¿CLEAN THE CONNECTOR CABLE WITH 70% ISOPROPYL ALCOHOL.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 55-YEAR-OLD MALE ON IMPELLA 5.5 SUPPORT DUE TO CARDIOMYOPATHY. WHILE ON SUPPORT, A PURGE BYPASS HAD TO BE DONE ON THE IMPELLA 5.5 DUE TO LEAKING AND CRACKING OF THE YELLOW CONNECTION AND PURGE FILTER. THE COMPLICATION WAS MANAGED BY PERFORMING A PURGE BYPASS USING A 20G ANGIOCATH NEEDLE FOR FIRST TRY. IT WAS THEN REPLACED THIS WITH ART LINE PRESSURE TUBING FOR THE BYPASS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541018 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2023197303 00813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male