BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24366258 · Received February 17, 2026

    Report

    Report Number
    1220648-2026-03361
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 23, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE CAUSE OF THE HEMODYNAMIC INSTABILITY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE DEVICE IN WRONG POSITION WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT ==> DEVICE LOT: 1982340 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW ==> THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    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

    A PATIENT WITH PRE-EXISTING RENAL INSUFFICIENCY REQUIRING DIALYSIS THERAPY PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS STAGE E, WITH AN INITIAL LACTATE OF 12.8 MMOL/L AND PH OF 7.0. THE PATIENT REQUIRED SUPPORT WITH MORE THAN TWO INOTROPES/VASOPRESSORS AS WELL AS RESPIRATORY ASSISTANCE. AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY, FOLLOWED BY PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT MAIN AND LEFT ANTERIOR DESCENDING ARTERIES. THE FIRST COMPLAINT WAS RAISED DUE TO RAPIDLY FLUCTUATING PLACEMENT SIGNALS; HOWEVER, NO IMMEDIATE INTERVENTION WAS TAKEN AS THE TREATING PHYSICIAN DID NOT WANT ANY ADDITIONAL RISK FOR THIS CRITICALLY ILL PATIENT. AFTER SUCCESSFUL PLACEMENT OF THE IMPELLA CP, THE PHYSICIAN REMOVED THE PEEL-AWAY SHEATH AND EXCHANGED IT FOR THE REPOSITIONING SHEATH. SUBSEQUENTLY, THE CONTROLLER GENERATED AN ¿IMPELLA IN THE AORTA¿ ALARM (SECOND COMPLAINT), AND FLUOROSCOPY CONFIRMED THE DEVICE POSITION IN THE AORTA. MULTIPLE ATTEMPTS TO REPOSITION THE DEVICE WERE UNSUCCESSFUL, AND A NEW IMPELLA CP WAS INSERTED. THE CASE WAS CODED AS DEVICE REPOSITIONING AND DEVICE REVISION OR REPACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430508 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026770249 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention