BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 23878907 · Received December 23, 2025

    Report

    Report Number
    1035166-2025-00067
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 4, 2025
    Report Date
    March 30, 2026
    Manufacturer
    INTEGER HOLDINGS CORPORATION
    Product Code
    DYB
    UDI-DI
    00885672009793
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, D9, D3, G1, G3, G6, H2, H6 & H11. THE DEVICE HAS NOT RETURNED FOR EVALUATION, NOR WERE ANY PICTURES PROVIDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE DEVICE, AND CUSTOMER STATED THE DEVICE HAS BEEN DISCARDED. THE CUSTOMER REPORTED THAT LEFT GROIN ACCESS ATTEMPTED NEXT BY THE INTERVENTIONAL CARDIOLOGISTS USING A 6 FRENCH SHEATH, HOWEVER; THE SHEATH COULD NOT BE ADVANCED. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED, AND THE RISK REMAINS ACCEPTABLE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTEGER WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. 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.

    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

    ON 26/JAN/2026 CUSTOMER REPORTED; THE FIELD REP HAS STATED THE PRODUCT WAS DISCARDED.

    Description of Event or Problem · 0

    COMPLAINT SUMMARY: WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING A OSCOR INTRO KIT, 14FR X 13 AND 25 CM (MATERIAL #0052-3025, LOT # DP-18438). "RIGHT GROIN ACCESS WAS SUCCESSFULLY OBTAINED FOR IMPELLA PLACEMENT. LEFT GROIN ACCESS ATTEMPTED NEXT BY THE INTERVENTIONAL CARDIOLOGISTS USING A 6 FRENCH SHEATH, HOWEVER THE SHEATH COULD NOT BE ADVANCED. THE CARDIOLOGIST REMOVED THE SHEATH FROM THE LEFT SIDE AND ACHIEVED HEMOSTASIS BY MANUAL COMPRESSION. RIGHT GROIN USED FOR SINGLE ACCESS PRO PCI. PRO PCI WAS SUCCESSFULLY PERFORMED USING SINGLE RIGHT GROIN ACCESS, THE IMPELLA DEVICE PROVIDED LEFT VENTRICULAR SUPPORT THROUGHOUT THE PROCEDURE. AT COMPLETION OF THE PROCEDURE THE PATIENT DEVELOPED TACHYCARDIC AND HYPOTENSION. CLINICAL ASSESSMENT REVEALED A LEFT GROIN HEMATOMA WITH ACTIVE BLEEDING. HEMODYNAMICS STABILISED. VASCULAR SURGEON CALLED TO ASSIST WITH LEFT GROIN BLEED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. IMPELLA WAS EXPLANTED 18.00 ONCE PATIENT WAS STABILISED. PATIENT WAS TAKEN TO THEATRES FOR GROIN EXPLORATION AND SURGICAL REPAIR OF THE LEFT GROIN." THE PRODUCT RETURN WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532026 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB INTEGER HOLDINGS CORPORATION 0052-3025 DP-18438 00885672009793

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention