BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24551536 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04816
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    November 26, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    ON (B)(6) 2025, A 76-YEAR-OLD WOMAN WITH A MEDICAL HISTORY SIGNIFICANT FOR DIABETES MELLITUS, END-STAGE RENAL DISEASE, AND PRIOR NON¿ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WAS NOTED TO BE VOLUME OVERLOADED WITH A NEW DECREASE IN LEFT VENTRICULAR EJECTION FRACTION. DIAGNOSTIC LEFT HEART CATHETERIZATION DEMONSTRATED SUBTOTAL OSTIAL DISEASE OF THE LEFT CIRCUMFLEX CORONARY ARTERY, AS WELL AS DISEASE INVOLVING THE DISTAL LEFT MAIN CORONARY ARTERY AND THE OSTIAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY FOR IMPELLA-SUPPORTED PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT MAIN CORONARY ARTERY, LEFT CIRCUMFLEX CORONARY ARTERY, AND LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE ILIAC VESSELS WERE NOTED TO BE TORTUOUS. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE PIGTAIL CATHETER, AND FLUOROSCOPIC IMAGING DEMONSTRATED KINKING OF THE LONG PEEL-AWAY SHEATH WITHIN THE ILIAC ARTERY DUE TO VESSEL TORTUOSITY. THE LONG SHEATH WAS EXCHANGED FOR A SHORT SHEATH, AND UPON REMOVAL, A CRACK WAS OBSERVED IN THE LONG PEEL-AWAY SHEATH AT THE SITE OF THE KINK. ALL EQUIPMENT HAD BEEN DELIVERED WITHOUT ISSUE THROUGH THE LONG SHEATH PRIOR TO EXCHANGE. THE PERCUTANEOUS CORONARY INTERVENTION WAS COMPLETED WITH INTERMITTENT PRESSURE DAMPENING DURING BALLOON INFLATIONS, AND THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS. THE IMPELLA DEVICE WAS GRADUALLY WEANED AND REMOVED. NO PATIENT INJURY OR ADVERSE CLINICAL EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605664 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9607283

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female