BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_INTRODUCER

    MDR report key: 24278448 · Received February 6, 2026

    Report

    Report Number
    1220648-2026-02449
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1, D4 BRAND NAME AND CATALOG NUMBER UPDATE FROM 14FR INTRODUCER TO 7FR INTRODUCER .(UNKNOWN PRODUCT NAME). D2A COMMON DEVICE NAME UPDATED. D2B PROCODE UPDATED. H6 MED DEV PROB CODE CHANGED TO A150206.

    Additional Manufacturer Narrative · 0

    THE INTRODUCER WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA CP WAS IMPLANTED VIA PERCUTANEOUS RIGHT FEMORAL ARTERY. THE COMPANION SHEATH DILATOR WAS UNABLE TO ADVANCE INTO THE SHEATH. THE 7 FRENCH COMPANION SHEATH TIP APPEARED NARROWED AND WOULD NOT ALLOW THE DILATOR TO BE ADVANCED INTO THE SHEATH. THE PROCEDURE WAS SUCCESSFUL WITH ANOTHER DEVICE. THERE WAS NO HARM AND THE PATIENT'S OUTCOME AT EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278197 UNK_INTRODUCER INTRODUCER, CATHETER DYB ABIOMED, INC. - 1220648 S9153495 00813502013269

    Patients

    Seq Age Sex Outcome Treatment
    1