BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 17795630 · Received September 21, 2023

    Report

    Report Number
    1220648-2023-03329
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 23, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RECEIVED FROM THE CUSTOMER HOWEVER, THE EVALUATION OF THE DEVICE IS NOT COMPLETE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE DELIVERY ISSUES- USE HAS BEEN COMPLETED. THE INTRODUCER WAS NOT RETURNED FOR REVIEW. THE GUIDEWIRE WAS RETURNED IN MULTIPLE BENT CONDITION (MOST LIKELY OCCURRED DURING PACKAGING TO RETURN TO ABIOMED). VISUAL INSPECTION FOUND NO ISSUES ON THE PUMP. THE PUMP PASSED OD RING GAUGE TEST INDICATING THAT THE PUMP OD WAS IN SPECIFICATION. THE ROOT CAUSE OF THE DIFFICULTY INSERTING PUMP THROUGH INTRODUCER WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND THE INTRODUCER WAS NOT RETURNED FOR REVIEW.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 79-YEAR-OLD MALE UNDERGOING CARDIAC SURGERY WAS EMERGENTLY IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. ONCE THE PUMP WAS OUT OF THE PEEL-AWAY SHEATH, IT KINKED ALONG WITH 0.18 WIRE AND THE PHYSICIAN WAS UNABLE TO ADVANCE IT FURTHER. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE, SO THE PUMP WAS COMPLETELY PULLED OUT OF THE BODY WITHOUT HARM TO THE PATIENT OR DEVICE. A NEW IMPELLA CP DEVICE WAS IMPLANTED THROUGH THE SAME ACCESS SITE WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614975 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024362395

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male