BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 23705915 · Received December 3, 2025

    Report

    Report Number
    1220648-2025-48760
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT RETURNED FOR EVALUATION. PRODUCT DAMAGE (GUIDEWIRE FRACTURE): CLINICAL DETAILS NOTED THAT THE GUIDEWIRE FRACTURED WHEN THE PUMP WAS BEING LOADED OVER THE GUIDEWIRE. NO ADDITIONAL DETAILS WERE PROVIDED. THE CAUSE OF THE PRODUCT DAMAGE (GUIDEWIRE FRACTURE) COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED AND LIMITED CLINICAL DETAILS WERE PROVIDED. DEVICE HISTORY LOT: DEVICE LOT: 8854085. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: 0.018" GUIDEWIRE LOT #8854085 PASSED ALL INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION

    Additional Manufacturer Narrative · 0

    THE GUIDEWIRE 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

    ADDITIONAL INFORMATION RECEIVED THAT THE MOST LIKELY EXPLANATION IS THAT A NURSE INADVERTENTLY ACTIVATED THE IMPELLA WHILE THE PHYSICIAN WAS ADVANCING IT INTO THE DESCENDING AORTA. THIS WOULD EXPLAIN WHY THE 0.018" GUIDEWIRE BECAME ENTRAPPED WITHIN THE IMPELLA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE LOADING OF THE IMPELLA CP ON THE 0.018", THE 0.018" BROKE IN THE IMPELLA. THE PHYSICIAN HAD NOT GONE THOUGH THE AORTIC VALVE BEFORE BREAKING THE GUIDEWIRE. THE PIGTAIL WAS STILL IN THE AORTA SO IT WAS NOT POSSIBLE TO PUSH THE PUMP IN THE LEFT VENTRICLE. THE PUMP AND THE GUIDEWIRE WERE REMOVED. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE GUIDEWIRE AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE PUMP. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849895 IMPELLA WIRE, GUIDE, CATHETER DQX ABIOMED, INC. GUIDE WIRE 0.018"PTFE COATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female