BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPC10 (CPSA) PUMP SET JAPAN

    MDR report key: 24594307 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05236
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    March 2, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013948
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMS THE IMPELLA PUMP PLACED FOR SUPPORT WAS EXPLANTED. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE IMPELLA DEVICE AND WAS REPORTED TO HAVE SURVIVED AT THE TIME OF EXPLANT. SECTION D6B HAS BEEN UPDATED ACCORDINGLY (WITH D6A REPOPULATED). ADDITIONALLY, INFORMATION CONFIRMS THE PATIENT'S WEIGHT AS PREVIOUSLY REPORTED AND REPOPULATED TO A4 WEIGHT.

    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

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY ACCESS SITE TO SUPPORT THE 69 YEAR OLD MALE ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. WHEN INSERTED THE CP PUMP THE TEAM HAD DIFFICULTY AND ONLY REACHED THE DESCENDING AORTA/ARCH. THE TEAM PULLED THE CP BACK TO THE INTRODUCER AND TROUBLESHOT THE DELIVERY BY INSERTING A 6FR SHEATH AT THE SINGLE ACCESS SITE AND CHANGING THE GUIDEWIRE TO THE STIFFER V18 GUIDEWIRE. THIS TROUBLESHOOTING ALLOWED THE CP TO BE SUCCESSFULLY DELIVERED TO THE LEFT VENTRICLE AND SUPPORT WAS INITIATED. THE CP REMAINS ON FOR SUPPORT TO DATE WITHOUT ANY NOTED MALFUNCTION OR HARM. THE FAILURE TO DELIVER AND ADVANCE WILL BE CONSERVATIVELY REPORTED FOR THE DELAY IN SUPPORT INITIATION, THOUGH THE DELIVERY WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652662 CPC10 (CPSA) PUMP SET JAPAN TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026814448 00813502013948

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male