BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24266928 · Received February 5, 2026

    Report

    Report Number
    1220648-2026-02289
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: HEMATOMA/ASAE: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 2002836. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A4. WEIGHT OF THE PATIENT IS UNKNOWN. DEVICE STATUS. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN AN 85-YEAR-OLD MALE PATIENT PRESENTING FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH A MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY DISEASE (CAD), DIABETES MELLITUS, RENAL INSUFFICIENCY, AND DIALYSIS DEPENDENCE. FOLLOWING COMPLETION OF SUPPORT, THE IMPELLA CP WAS REMOVED, AND VASCULAR CLOSURE WAS PERFORMED USING ONE 8-FR ANGIO-SEAL AND ONE PERCLOSE DEVICE. AFTER DEVICE REMOVAL AND CLOSURE, A SMALL BLEED WITH A SMALL HEMATOMA WAS NOTED AT THE FEMORAL ACCESS SITE. MANUAL PRESSURE WAS APPLIED FOR 20 MINUTES, FOLLOWED BY AN ADDITIONAL 15 MINUTES, RESULTING IN STABILIZATION OF THE SITE. THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU) FOR INCREASED MONITORING. NO BLOOD PRODUCTS WERE REQUIRED, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE ACCESS-SITE BLEEDING AND HEMATOMA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH LARGE-BORE ARTERIAL ACCESS AND THE ANTICOAGULATION REQUIREMENTS OF IMPELLA SUPPORT, AS DESCRIBED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, THE HEMATOMA WAS IDENTIFIED FOLLOWING PLANNED DEVICE EXPLANT, WAS MANAGED WITH STANDARD MEASURES, AND DID NOT RESULT IN HEMODYNAMIC COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440033 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026785049 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other