BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, 23FR INTRODUCER, 11CM, STERILE

    MDR report key: 24333854 · Received February 13, 2026

    Report

    Report Number
    1220648-2026-03143
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    February 8, 2026
    Report Date
    February 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502010411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. BLEEDING WAS FROM THE PEEL AWAY SHEATH VALVE; PEEL AWAY SHEATH WAS REMOVED AFTER INSERTION.

    Additional Manufacturer Narrative · 0

    D6B: ADDED EXPLANT DATE.

    Additional Manufacturer Narrative · 0

    B5: ADDED UPDATED CLINICAL REVIEW. H6: OMITTED A150302 AND ADDED A050401.

    Additional Manufacturer Narrative · 0

    D4 AND H4 UPDATED WITH MISSING INFORMATION.

    Additional Manufacturer Narrative · 0

    D6B: THE EXPLANT DATE IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX WAS INSERTED VIA LEFT AXILLARY VEIN IN A 57 YEAR OLD FEMALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT'S COMORBIDITIES WERE NOT INCLUDED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING PLACEMENT, BLEEDING WAS OBSERVED FROM THE 23FR SHEATH VALVE AFTER THE DILATOR REMOVED. THE TEAM PEELED AWAY THE 23FR SHEATH AND SUPPORT PROCEEDED ON THE PUMP. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX WAS INSERTED VIA LEFT AXILLARY VEIN IN A 57-YEAR-OLD FEMALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE NOT INCLUDED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING PLACEMENT, BLEEDING WAS OBSERVED FROM THE 23FR SHEATH VALVE AFTER THE DILATOR REMOVED. BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT OF THE IMPELLA RP FLEX PER THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140320 KIT, 23FR INTRODUCER, 11CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9241387 00813502010411

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other