BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24499865 · Received March 3, 2026

    Report

    Report Number
    1220648-2026-04420
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    October 14, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 REVISED.

    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 77 YEAR OLD MALE WITH A HISTORY OF ATRIAL FIBRILLATION, AORTIC VALVE REPLACEMENT WITH DE NOVO SEVERE AORTIC INSUFFICIENCY AND CORONARY ARTERY DISEASE COLLAPSED AT HOME AND WAS FOUND PULSELESS. RESUSCITATION WAS PERFORMED AND CIRCULATION RESTORED ON HOSPTIAL ARRIVAL. A TRANS-CATHETER AORTIC VALVE REPLACEMENT WITH IMPLANTATION OF IMPELLA CP WAS CARRIED OUT DUE TO THE PATIENT¿S HEMODYNAMIC INSTABILITY. ONCE THE PUMP WAS STARTED AFTER PLACEMENT, FLOWS REMAINED LOW AND SUCTION EVENTS AS WELL AS NO AORTIC PLACEMENT SIGNAL WERE NOTED. TEE CONFIRMED PLACEMENT AS WELL AS FLUOROSCOPY. THE DEVICE WAS REMOVED AND REPLACEMENT BY ANOTHER CP WAS ATTEMPTED. WHILE ATTEMPTING TO RE-WIRE THE EXISTING PEEL-AWAY SHEATH, A LARGE KINK WAS NOTED IN THE MID PORTION NOT ALLOWING THE WIRE TO PASS. A CANNULA KINK WAS NOTED. DUE TO NOTED TORTUOSITY IN LEFT ILIAC ARTERY, THE PHYSICIAN DECIDED NOT TO PLACE A NEW DEVICE. THE SHEATH WAS REMOVED AND SITE WAS CLOSED.

    Description of Event or Problem · 0

    A 77 YEAR OLD MALE WITH A HISTORY OF ATRIAL FIBRILLATION, AORTIC VALVE REPLACEMENT WITH DE NOVO SEVERE AORTIC INSUFFICIENCY AND CORONARY ARTERY DISEASE COLLAPSED AT HOME AND WAS FOUND PULSELESS. RESUSCITATION WAS PERFORMED AND CIRCULATION RESTORED ON HOSPITAL ARRIVAL. A TRANS-CATHETER AORTIC VALVE REPLACEMENT WITH IMPLANTATION OF IMPELLA CP WAS CARRIED OUT DUE TO THE PATIENT¿S HEMODYNAMIC INSTABILITY. ONCE THE PUMP WAS STARTED AFTER PLACEMENT, FLOWS REMAINED LOW AND SUCTION EVENTS AS WELL AS NO AORTIC PLACEMENT SIGNAL WERE NOTED. THE DEVICE WAS REMOVED AND REPLACEMENT BY ANOTHER CP WAS ATTEMPTED. WHILE ATTEMPTING TO RE-WIRE THE EXISTING PEEL-AWAY SHEATH, A LARGE KINK WAS NOTED IN THE MID PORTION NOT ALLOWING THE WIRE TO PASS. DUE TO NOTED TORTUOSITY IN LEFT ILIAC ARTERY, THE PHYSICIAN DECIDED NOT TO PLACE A NEW DEVICE. THE SHEATH WAS REMOVED AND SITE WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484281 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9517180

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male