BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23420376 · Received October 29, 2025

    Report

    Report Number
    1220648-2025-47941
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E4. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. ISCHEMIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED PATIENT WAS PLACED ONTO IMPELLA SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION / CARDIOGENIC SHOCK. PULSES WERE PALPABLE BEFORE PROCEDURE, BUT NON DOPPLERABLE POST IMPELLA INSERTION D/T REDUCED PULSATILITY. ANGIO REVEALED NO FLOW BEYOND INSERTION POINT OF ARTERIOTOMY. EXTERNAL BYPASS PLACED FROM LEFT COMMON FEMORAL ARTERY (CFA) TO RETROGRADE DISTAL RIGHT CFA. THEREFORE A 6FR SHEATH PLACED RETROGRADE IN RIGHT CFA DISTALLY TERMINATING JUST DISTAL TO INSERTION SITE. DONOR 6FR SHEATH IN LEFT CFA EXTERNALLY BYPASSING RIGHT CFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380556 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER , CATHETER (INTRODUCER) DYB ABIOMED, INC. KIT, 14FR INTRODUCER, 13CM&25CM, STERILE S9596063

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention