BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 25191615 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07923
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013474
    Product Problem
    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

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE ROOT CAUSE OF THE DELIVERY ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENTS VESSEL SIZE WAS TOO SMALL IN TWO ACCESS SITES.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THERE WAS AN ATTEMPT TO IMPLANT AN IMPELLA CP DEVICE IN A PATIENT FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPLANTATION, THE MEDICAL TEAM WAS UNABLE TO GET ACCESS TO THE RIGHT COMMON FEMORAL ARTERY WITH THE 14 FRENCH SHEATH. ACCESS WAS ATTEMPTED ON THE LEFT SIDE WITH SAME RESULT. THE DOCTOR VERBALIZED THAT THE VESSEL SIZE WAS TOO SMALL. AT THAT POINT, THE CASE WAS ABORTED. THE PRODUCT WAS DISCARDED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429700 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S10082875 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1