BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC PUNCH

    MDR report key: 12634867 · Received October 14, 2021

    Report

    Report Number
    1645362-2021-00003
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 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 · 0

    AORTIC PUNCH DOES NOT RELEASE. PATIENT WAS ADMITTED FOR ELECTIVE CORONARY ARTERY BYPASS GRAFT UNDER MR. DW IN CT2. WHILE CASE WAS ONGOING, SURGEONS USED THE AORTIC PUNCH ON THE AORTA TO MAKE A HOLE BUT THE PUNCH GOT STUCK ON THE AORTA AND DOES NOT RELEASE. THEY ENDED UP CUTTING AROUND THE AORTA TO RELEASE THE PUNCH. THE SURGERY WAS COMPLETE SUCCESSFULLY WITH NO FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529085 AORTIC PUNCH AORTA PUNCH, SINGLE USE DWS INTERNATIONAL BIOPHYSICS CORPORATION APL44 041221-10024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention