BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24578617 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05130
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    November 4, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 0

    A 68 YEAR OLD MAN UNDERWENT SUCCESSFUL IMPELLA CP SUPPORTED HRPCI. ON REMOVAL OF THE PEEL AWAY SHEATH THE PHYSICIAN FELT THERE WAS A POSSIBILITY THE REPO SHEATH MAY HAVE BEEN PERFORATED, AND THUS THE IMPELLA WAS EXPLANTED AND THE GROIN CLOSED IN THE USUAL FASHION. NO PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451968 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9557227

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male