BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE A, 0.018" PTFE, JP

    MDR report key: 24454152 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04076
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DQX
    UDI-DI
    4260113630303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE WAS CHANGED TO A150202.

    Additional Manufacturer Narrative · 0

    B5 ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE GUIDEWIRE AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE IMPELLA CP. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE DEATH WAS DUE TO CEREBRAL INFARCTION DUE TO THE TIME REQUIRED FROM TRANSPORT TO IMPELLA INSERTION. THE DEATH WAS NOT RELATED TO THE DISCONTINUATION OF IMPELLA IMPLANTATION.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE PLACED ON AN IMPELLA CP. THE CP WAS PLACED, BUT IT WAS REMOVED DUE TO A POSITIONING ISSUE. AN ATTEMPT WAS MADE TO PLACE IT AGAIN, BUT THE 18-WIRE COULD NOT BE INSERTED. THE DETAILS OF WHY THE WIRE COULD NOT BE PLACED ARE CURRENTLY UNKNOWN. THE GUIDEWIRE DISCONNECTED FROM THE LEFT VENTRICLE. THE DOCTOR COMMENTED "THIS WAS DUE TO THE PROCEDURE. THERE WERE NO PROBLEMS WITH INSERTION OR THE DEVICE.". A SECOND CP WAS OPENED AND PLACED AGAIN. THE PATIENT'S OUTCOME WAS THE PATIENT DIED. THE DEATH WAS NOT RELATED TO THE DISCONTINUATION OF THE IMPELLA IMPLANTATION. THE DEATH WAS BRAIN-RELATED AS RESUSCITATION TOOK TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154850 GUIDEWIRE A, 0.018" PTFE, JP WIRE, GUIDE, CATHETER DQX ABIOMED, INC. - 1220648 8854006 4260113630303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown