BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23603936 · Received November 20, 2025

    Report

    Report Number
    1220648-2025-48496
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H6 (COMPONENT CODE). THE CAUSE OF THE BLEED/ HEMATOMA WAS MOST LIKELY USE ISSUE RELATED SINCE THE USER PLACED THE BLUE SUTURE HUB INTO THE SKIN WHICH IS NOT ADVISED WITH THE USE OF CP.

    Additional Manufacturer Narrative · 0

    H6: ADDED TYPE OF INVESTIGATION CODES B11 AND B13 H11: ADDED THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED. MINOR BLEED/ HEMATOMA: THE CAUSE OF THE BLEED/ HEMATOMA WAS MOST LIKELY USE ISSUE RELATED SINCE THE USER PLACED THE BLUE SUTURE HUB INTO THE SKIN WHICH IS NOT ADVISED WITH THE USE OF CP. DIFFICULT TO PLACE OR POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1947612 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 HAD MINOR BLEEDING AND THAT THEY ENCOUNTERED POSITIONING ISSUES. THE PATIENT HAD A SMALL HEMATOMA AT THE IMPELLA CP SITE THAT INCREASED. MANUAL PRESSURE WAS HELD TO THE SITE, THE HEMATOMA WAS EXPRESSED AND THE SITE BECAME STABLE. ADDITIONALLY, THE IMPELLA HAD ANOTHER ¿IN AORTA¿ ALARM THAT HAD NOT RESOLVED. THE IMPELLA WAS SWITCHED TO P-2 AND THE DOCTOR WAS TO BE AT BEDSIDE TO REPOSITION UNDER ECHO AS SOON AS POSSIBLE. THE DOCTOR PERFORMED A POCUS AND THE PIGTAIL APPEARS TO STILL BE ACROSS THE VALVE. EXTENSIVE EDUCATION WAS PROVIDED TO THE CARE TEAM. THE PATIENT REMAINED ON IMPELLA SUPPORT FOR TWO DAYS. THE PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293482 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026699720 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention