BEUDAMED
    FDA Adverse Event Other Summary report: N

    RETROGRADE CARDIOPLEGIA CANNULA

    MDR report key: 518190 · Received March 25, 2004

    Report

    Report Number
    6000002-2004-00054
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    February 23, 2004
    Report Date
    February 27, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SUTURE RING BECAME LOOSE AND HAD REPORTEDLY DAMAGED THE CORONARY SINUS WHERE CANNULA WAS INSERTED. THE SURGEON WAS ABLE TO REPAIR AS A POST OP PROCEDURE. NO PERMANENT PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGRADE CARDIOPLEGIA CANNULA RETROGRADE CARDIOPLEGIA CANNULA DWF EDWARDS LIFESCIENCES RC2012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention