BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21559837 · Received March 10, 2025

    Report

    Report Number
    1220648-2025-26594
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    DYB
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF INTRODUCER DAMAGE ¿ MECHANICAL HAS BEEN COMPLETED. THE FAILURE MODE INTRODUCER DAMAGE WAS CHANGED TO ACCESS SITE BLEEDING AS IT WAS NOTED THERE WAS NOTICEABLE LEAKING FORM THE INTRODUCER HUB. THE PRODUCT WAS RETURNED AND THE INTRODUCER WAS LEAK TESTED. A LEAK WAS NOTED TO BE COMING OUT FROM UNDER THE ORANGE VALVE. IT LEAKED AROUND 50 MMHG WHICH LOWER THAN THE 180 MMHG PER SPECIFICATIONS. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING IS MOST LIKELY DUE TO A DAMAGED VALVE. B.1 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 BASED ON THE INVESTIGATION RESULTS. B.2 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 BASED ON THE INVESTIGATION RESULTS. B.7 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594. D.1 REVISED BRAND NAME AND PRODUCT CODE SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. D.2 REVISED COMMON DEVICE NAME SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. D.4 REVISED SECTION SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. SERIAL NUMBER, EXPIRATION AND UNIQUE IDENTIFIER (UDI) # SHOULD HAVE BEEN REFLECTED AS BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594. D.10 ADDED PUMP INFORMATION SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. E.1 ADDED US PHONE NUMBER AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H.1 REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 BASED ON THE INVESTIGATION RESULTS. H.6 REVISED COMPONENT CODE SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE AND HEALTH EFFECT - IMPACT CODE REVISED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 BASED ON THE INVESTIGATION RESULTS. CODE 3233 SHOULD HAVE BEEN ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26594 AS THE INVESTIGATION WAS IN PROCESS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. A LEAK WAS NOTED AROUND THE TOP OF THE PLASTIC ORANGE HUB OF THE 14FR SHORT SHEATH. THERE WAS NO PATIENT HARM AND SUPPORT CONTINUED UNINTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031104 KIT, 14FR INTRODUCER, 13&25 CM, ABMD INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. KIT, 14FR INTRODUCER, 13CM&25CM, STERILE S9085900 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Other IMPELLA CP SERIAL NUMBER (B)(6).