BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS HIGH FLOW AORTIC ARCH CANNULA

    MDR report key: 79296 · Received March 26, 1997

    Report

    Report Number
    1828100-1997-00006
    Event Type
    Malfunction
    Date Received
    March 26, 1997
    Date of Event
    February 20, 1997
    Report Date
    March 26, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BEFORE THE SURGEON PLACED THE CANNULA IN THE PT'S AORTA, HE NOTICED THAT THE SUTURE FLANGE WAS DEFORMED IN SUCH A WAY THAT, IF THE CANNULA HAD BEEN PLACED, THE FLANGE MAY HAVE CUT INTO THE AORTIC TISSUE AND RESULTED IN A SITUATION WHERE THERE WAS POTENTIAL FOR AORTIC DISSECTION. THE CANNULA INVOLVED IN THIS EVENT WAS NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS HIGH FLOW AORTIC ARCH CANNULA ARTERIAL CANNULA DQR 3M HEALTH CARE SARNS AND CDI PRODUCTS 98-0702-0044-2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other