BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24573215 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05086
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    December 19, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASAE/MINOR BLEED: AFTER PEEL AWAY SHEATH WAS REMOVED AND REPOSITIONING SHEATH INSERTED, REPORTED CONTINUOUS OOZING FROM ACCESS SITE DESPITE ANGLE MATCHING. DECISION MADE BY MD TO USE FEMSTOP FOR HEMOSTASIS. HEMOSTASIS ACHIEVED WITH FEMSTOP. POSITIVE DISTAL PULSES CONFIRMED VIA DOPPLER. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 60-YEAR-OLD MALE UNDERGOING SUPPORT FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE C, UNDERWENT PLACEMENT OF AN IMPELLA DEVICE (PUMP 1: (B)(4), GU CASE (B)(4). FOLLOWING REMOVAL OF THE PEEL AWAY SHEATH AND INSERTION OF THE REPOSITIONING SHEATH, PERSISTENT OOZING WAS OBSERVED AT THE RIGHT FEMORAL ARTERIAL ACCESS SITE DESPITE ATTEMPTS AT ANGLE ADJUSTMENT. THE ATTENDING PHYSICIAN ELECTED TO APPLY A FEMSTOP DEVICE, WHICH SUCCESSFULLY ACHIEVED HEMOSTASIS. BASED ON THE INFORMATION PROVIDED, THE ACCESS SITE OOZING APPEARS RELATED TO PROCEDURAL FACTORS INHERENT TO PERCUTANEOUS FEMORAL ARTERIAL ACCESS, AND HEMOSTASIS WAS EFFECTIVELY ACHIEVED WITH MECHANICAL COMPRESSION. THE TRANSIENT YELLOW CONTROLLER ERROR ALARM RESOLVED SPONTANEOUSLY AND WITHOUT CLINICAL IMPACT. AT THIS TIME, THERE IS NO EVIDENCE INDICATING A DEVICE MALFUNCTION, THOUGH FURTHER INVESTIGATION OF THE REPORTED CONTROLLER ALARM IS WARRANTED PER THE ACCOUNT¿S REQUEST. BLEEDING IS A FORESEEABLE RISK DUE TO VASCULAR ACCESS AND ANTICOAGULATION REQUIREMENTS AND IS IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT SURVIVED EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222750 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025560996 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention