BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 24437252 · Received February 24, 2026

    Report

    Report Number
    1220648-2026-03957
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    February 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013269
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    D3 (MANUFACTURER FAX) HAS BEEN ADDED. MINOR BLEED/HEMATOMA/ASAE: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS IMPLANTED IN A 64-YEAR-OLD MALE VIA LEFT FEMORAL ARTERY ACCESS FOR MANAGEMENT OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE E). THE PATIENT HAD KNOWN CORONARY ARTERY DISEASE AND DIABETES MELLITUS AND WAS RECEIVING EXTRACORPOREAL MEMBRANE OXYGENATION, INOTROPES, VASOPRESSORS, AND VENTILATOR SUPPORT AT THE TIME OF IMPLANTATION. PRE-IMPLANT LABORATORY VALUES INCLUDED A LACTATE OF 12.0 MMOL/L AND ALT OF 276 U/L, CONSISTENT WITH SEVERE SHOCK PHYSIOLOGY. THE PURGE SOLUTION CONSISTED OF D5W WITH 25 MEQ SODIUM BICARBONATE. THE COMPLAINT STATES THAT A HEMATOMA DEVELOPED IN THE GROIN ACCESS AREA WITH ASSOCIATED MINOR BLEEDING. NO BLOOD TRANSFUSION WAS REPORTED, AND NO SURGICAL INTERVENTION WAS REQUIRED. THE ACCESS SITE WAS READDRESSED WITH LOCAL MANAGEMENT, AFTER WHICH NO FURTHER ESCALATION OF CARE WAS DESCRIBED. HEMATOMA AND MINOR BLEEDING AT FEMORAL ACCESS SITES ARE KNOWN AND EXPECTED RISKS ASSOCIATED WITH LARGE-BORE ARTERIAL ACCESS AND ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. CONTRIBUTING FACTORS MAY INCLUDE ANTICOAGULATION, SHOCK-RELATED COAGULOPATHY, VASOPRESSOR USE, AND UNDERLYING CRITICAL ILLNESS. DUE TO ONGOING HEMODYNAMIC INSTABILITY, THE PATIENT WAS ESCALATED TO AN IMPELLA 5.5 FOR CONTINUED CIRCULATORY SUPPORT. NO ADDITIONAL DEVICE-RELATED CONCERNS WERE REPORTED FOLLOWING ESCALATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED HEMATOMA AND MINOR BLEEDING WERE MANAGED CONSERVATIVELY AND ARE CONSISTENT WITH KNOWN ACCESS-SITE RISKS IN THE SETTING OF LARGE-BORE ARTERIAL CANNULATION AND SEVERE CARDIOGENIC SHOCK. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382936 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9596072 00813502013269

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention