BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, LOW PROFILE, 14FR, SHORT, POUCH, ST

    MDR report key: 24747831 · Received March 31, 2026

    Report

    Report Number
    1220648-2026-06197
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Description of Event or Problem · 0

    AN INTRA AORTIC BALLOON PUMP (IABP) WAS EXCHANGED FOR AN IMPELLA CP10 WITH THE 14FR LOW PROFILE SHEATH VIA THE RIGHT FEMORAL ARTERY IN A 64 YEAR OLD FEMALE PATIENT FOR PROTECTED PERCUTANEOUS INTERVENTION. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D BEING SUPPORTED BY AN IABP. THE PATIENT WENT TO THE ICU ON SUPPORT WITH THE 14 FR LOW PROFILE SHEATH IN PLACE AS INSTRUCTED IN THE IFU. POST PROCEDURE IT WAS NOTED THAT THE IMPELLA INSERTION SITE WAS OOZING. IT IS IMPORTANT TO APPRECIATE THE RISK OF UTILIZING THE SAME ARTERIOTOMY WHEN EXCHANGING THE IABP FOR THE IMPELLA. THE PHYSICIAN VOICED THAT THEY FELT THE INITIAL STICK FOR IABP WAS HIGH WHICH WAS CONTRIBUTING TO THE OOZING. STANDARD TROUBLESHOOTING AND REDRESSING THE SITE RESOLVED THE OOZE. AFTER APPROXIMATELY 24 HOURS OF SUPPORT THE PATIENT WAS TAKEN BACK TO THE CATH LAB FOR REMOVAL AT WHICH TIME THE ACCESS SITE WAS FLAT AND DRY. UPON REMOVAL OF THE DEVICE THERE WERE NOTED CONCERNS OF THROMBUS BUT NO DOCUMENTED THROMBUS RELATED ADVERSE EVENT TO THE PATIENT. IN FURTHER DISCUSSIONS REGARDING THE THROMBOSIS THERE WAS INFORMATION SHARED THAT THE THROMBUS REQUIRED MULTIPLE ASPIRATIONS TO REMOVE THE CLOT BURDEN. BY THE 3RD ASPIRATION THE CLOT BURDEN WAS REMEDIED AND THE ASPIRATION WAS CLEAR. WHILE ON SUPPORT THE DEVICE FUNCTIONED WITHIN EXPECTED FLOW RANGE P-6 2.7L/MIN. PERCUTANEOUS CORONARY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801983 KIT, LOW PROFILE, 14FR, SHORT, POUCH, ST INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention