BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24302827 · Received February 10, 2026

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    Report

    Report Number
    1220648-2026-02679
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    February 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1. BRAND NAME UPDATED. D4. CATALOG UPDATED.

    Additional Manufacturer Narrative · 0

    B3: UPDATED DATE OF EVENT.

    Additional Manufacturer Narrative · 0

    THE INTRODUCER 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.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS TO BE PLACED VIA THE FEMORAL ARTERY FOR THE 34-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH CARDIOMYOPATHY AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. UPON ACCESSING THE FEMORAL THE TEAM NOTED THE 14FR INTRODUCER SHEATH HAD A PORTION OF THE SHEATH BREAK, THE BREAKAGE LEAD TO A PROFUSE GROIN SITE BLEED. THE TEAM PLACED A NEW SHEATH TO ACHIEVE HEMOSTASIS. THE PUMP SUPPORTED FOR 4 DAYS AND WAS THEN WEANED AND EXPLANTED. NO FURTHER TREATMENT WAS NOTED FOR THE BLEEDING. THE INTRODUCER DAMAGE AND ASSOCIATED BLOOD LOSS WILL BE REPORTED FOR THE DELAY; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO LASTING CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510256 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 S9913594

    Patients

    Seq Age Sex Outcome Treatment
    1