BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 24168070 · Received January 23, 2026

    Report

    Report Number
    1035166-2026-00004
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    May 27, 2026
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672009755
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. INTEGER IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY INTEGER WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN AXILLARY INSERTION INTRODUCER (MATERIAL#: 0052-3006, LOT#: S9408529). BLEEDING NOTED DURING ARTERIOTOMY ACCESS. THIS IS YOUR NOTIFICATION OF A DAMAGE/COMPLAINT OF THE AXILLARY INSERTION INTRODUCER, LOT: S9408529, PART NUMBER: 0052-3006. 08/JAN/2026 CUSTOMER REPORTED EVENT OCCURRED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96931 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3006 S9408529 00885672009755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention