BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24541826 · Received March 8, 2026

    Report

    Report Number
    1220648-2026-04683
    Event Type
    Malfunction
    Date Received
    March 8, 2026
    Date of Event
    November 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE IS NO DEVICE AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 0

    PRODUCT-SPECIFIC INFORMATION (D4 UNIQUE DEVICE IDENTIFIER, D4 EXPIRATION DATE, AND H4 DATE OF MANUFACTURE) IS UNKNOWN AT THE TIME OF THIS MDR WRITING AND FIELDS HAVE BEEN NOTED AS UNKNOWN OR LEFT BLANK AS APPROPRIATE. 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 79-YEAR-OLD MAN UNDERWENT HRPCI WITH IMPELLA CP AFTER SURGICAL CUT DOWN FOR RIGHT SUBCLAVIAN ARTERIAL ACCESS. ON REMOVAL OF THE DILATOR THE PEEL AWAY SHEATH COLLAPSED BUT STILL PERMITTED THE PUMP TO BE INSERTED. THE CASE WAS SUCCESSFULLY COMPLETED AND THE DEVICE EXPLANTED IN THE USUAL FASHION. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43497 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. S9467396

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male