BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24597682 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05231
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    December 31, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMITTED CODE A0709 AND ADDED CODE A140505.

    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

    A 47 YEAR OLD MALE PATIENT WAS TRANSFERRED FROM IMPELLA 5.5 TO IMPELLA CP SUPPORT ON (B)(6) 2025. DURING IMPELLA 5.5 SUPPORT, ON (B)(6) 2025, LEFT VENTRICLE PERFORATION OCCURRED WHILE MANIPULATING AND POSITIONING IMPELLA IN VENTRICLE. ON (B)(6) 2025, PHYSICIAN BELIEVED THAT THE PATIENT WAS ENCOUNTERING VENTRICULAR TACHYCARDIA RELATED TO IMPELLA 5.5 POSITIONING ISSUES. DOCTOR STATED THAT THE GRAFT HAD BEEN SEWN ON PER THE IFU RECOMMENDATION. HOWEVER, THE DECISION WAS MADE TO EXPLANT THE 5.5 AND REPLACE WITH A CP DEVICE. DURING IMPELLA CP SUPPORT, 17 DAY OLD CP BEGAN TO SHOW SIGNS OF MOTOR FAILURE, VARYING PURGE FLOWS, LEFT VENTRICLE WAVEFORMS ELEVATION, AND MOTOR CURRENT ELEVATION ABOVE 1200 RPMS. THE IMMEDIATE DECISION WAS MADE TO TAKE THE PATIENT BACK TO THE CATHETERIZATION LABORATORY TO EXCHANGE FOR A NEW IMPELLA CP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657316 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026788320 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention