BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC PUNCH

    MDR report key: 12482944 · Received September 16, 2021

    Report

    Report Number
    1645362-2021-00002
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 14, 2021
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Product Code
    DWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED FOR ELECTIVE CORONARY ARTERY BYPASS GRAFT UNDER MS AN IN CT2. WHEN WE WERE ON THE TOP END OF THE GRAFT ON THE AORTA, THE AORTIC PUNCH GOT STUCK INSIDE THE AORTA AND DID NOT RELEASE. THIS CAN CAUSE SERIOUS DAMAGE TO THE AORTA AND DISSECT IT. THE SURGEON NEEDED TO CUT OFF AROUND IT TO RELEASE THE AORTIC PUNCH. THE SURGERY WAS COMPLETE SUCCESSFULLY WITH NO FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382654 AORTIC PUNCH AORTA PUNCH, SINGLE USE DWS INTERNATIONAL BIOPHYSICS CORPORATION APL44 070820-9728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention