BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24092660 · Received January 16, 2026

    Report

    Report Number
    1220648-2026-00886
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 28, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6. THIS REPORT IS SUBMITTED AS A FOLLOW UP TO PROVIDE ADDITIONAL INFORMATION OBTAINED AFTER THE INITIAL MDR SUBMISSION. 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

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THERE WAS OOZING BLOOD FROM THE INSERTION SITE. EXTRA DRESSINGS HAD TO BE APPLIED. BLOOD LOSS ESTIMATED 150CC. HEMOGLOBINE 8,6 AT 14:19 HOURS, HEMOGLOBINE 14:23 8,2, BUT ALSO 500 CC GELOFUSINE AND 500 RINGERS LACTATE GIVEN RAPIDLY VIA CENTRAL 3 LUMEN LINE. OOZING UNDER CONTROL. NO BLOOD PRODUCTS GIVEN. HEARTBEAT WAS STILL 8.2 AT 14:58. POSITIONING SHEATH WAS INSERTED ( 3 CM TO BE INSERT) AND BLEEDING STOPPED ALMOST IMMEDIATELY. SUTURED AND POSITION CONFIRMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). ANTIBIOTICS WERE STARTED. THE PATIENT SURVIVED EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160483 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER OZD ABIOMED, INC. - 1220648 S9686994 00813502013269

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other