BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER (INTRODUCER)

    MDR report key: 25199812 · Received May 18, 2026

    Report

    Report Number
    1220648-2026-07934
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00885672009755
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE A01 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS AT THE AORTA FOR THE PATIENT ADMITTED IN WITH PLAN FOR A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY DUE TO MULTIVESSEL CORONARY ARTERY DISEASE. THE PATIENT PRESENTED AT SCAI STAGE E SHOCK AT THE ELECTIVE PUMP IMPLANT. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE 5.5 WAS PLACED VIA THE 23FR SHEATH AND 10MM GELWEAVE GRAFT. THE INSTRUCTIONS FOR USE SPEAK TO A 10MM X20 HEMASHIELD PLATINUM GRAFT. AFTER THE GRAFT WAS ACCESSED WITH THE 23FR INTRODUCER THE TEAM APPLIED THE GRAFT LOCKS, HOWEVER THERE WAS PERSISTENT BLEEDING OUTSIDE THE DISTAL END OF THE GRAFT. TO REMEDY THE BLEED THEY HAD TO PLACE 3 HEAVY SILK TIES TO ACHIEVE HEMOSTASIS. THE TROUBLESHOOTING WAS NECESSARY DESPITE THE TEAM USING ALL BEST PRACTICES AT THE ACCESS. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF MAJOR CARDIAC SURGERY AND DIRECT SURGICAL AORTIC ACCESS. THE PUMP REMAINED ON FOR SUPPORT TO DATE TILL WEAN AND EXPLANT. NO OTHER INTERVENTION, SUCH AS BLOOD PRODUCT DELIVERY, HAD BEEN DEEMED NECESSARY. THE PATIENT SURVIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57232 INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9913578 00885672009755

    Patients

    Seq Age Sex Outcome Treatment
    1