BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24189053 · Received January 27, 2026

    Report

    Report Number
    1220648-2026-01568
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE FINAL INVESTIGATION CONCLUSIONS. H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: MAJOR BLEED/ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: A 74 YEAR OLD MALE WITH AN INDICATION FOR USE OF MECHANICAL CIRCULATORY SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK UNDERWENT PLACEMENT OF AN IMPELLA CP (PUMP 1, PC (B)(4), GU CASE (B)(6)) VIA LEFT FEMORAL ARTERIAL PERCUTANEOUS ACCESS ON (B)(6) 2026 AT 12:54 PM. ON (B)(6) 2026, THE PATIENT EXPERIENCED GROIN ACCESS SITE BLEEDING. NURSING STAFF CHANGED THE DRESSING AND APPLIED A FEMSTOP DEVICE, AFTER WHICH THE BLEEDING SUBSIDED. THE IMPELLA CP (SN (B)(6)) REMAINED IN USE UNTIL EXPLANT ON (B)(6) 2026 AT 7:20 PM. THE PATIENT WAS SUBSEQUENTLY BRIDGED TO ADDITIONAL SUPPORT: IMPELLA RP FLEX (CASE (B)(6), SN (B)(6)) ON (B)(6) 2026 AT 1:20 PM AND IMPELLA 5.5 (CASE (B)(6), SN (B)(6)) ON (B)(6) 2026 AT 7:20 PM. THE REPORTED EVENT OF ACCESS SITE BLEEDING WAS MANAGED CONSERVATIVELY WITH DRESSING CHANGE AND FEMSTOP APPLICATION, RESULTING IN RESOLUTION OF THE BLEEDING. NO DEVICE MALFUNCTION WAS REPORTED, AND THE PATIENT SURVIVED TO EXPLANT. THE EVENT IS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH FEMORAL ARTERIAL ACCESS AND IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252372 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026798908 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention