BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 21896715 · Received April 23, 2025

    Report

    Report Number
    1220648-2025-27790
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 23, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012200
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WILL NOT BE 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF PRODUCT DAMAGE - SLEEVE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. SHOULD ANY NEW INVESTIGATION RESULTS BE RECEIVED REGARDING VASCULAR DAMAGE - PERIPHERAL VESSEL AND SUPPLEMENTAL REPORT WILL BE SUBMITTED. B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. B2 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. B5 ADDITIONAL INFORMATION THAT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. D4 MODEL NUMBER WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. G2 REPORT SOURCE; FOREIGN WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. H6 HEALTH EFFECT - CLINICAL CODE 4582 WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790. NEW CODES ADDED TO HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE H6 COMPONENT CODE 4723 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27790.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE IMPELLA CP STERILE SLEEVE WAS TORN. THE STERILITY WAS MAINTAINED BY STERILE TAPE SEALED ONTO STERILE SHEATH AND TOUGHY. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    ADDITIONALLY, THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM TO REMOVE THE IMPELLA AND HAVE VASCULAR REPAIR FOR THE FEMORAL ARTERY FOR ITS SURGICAL CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679276 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025539824 00813502012200

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention