BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL VENOUS DRAINAGE CANNULA

    MDR report key: 71466 · Received February 27, 1997

    Report

    Report Number
    55108-1997-00003
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 24, 1997
    Manufacturer
    DLP, INC.
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING FEMORAL VENOUS CANNULATION FOR ESTABLISHING FEMORAL-FEMORAL BYPASS FOR A MITRAL VALVE REPAIR. THE GUIDEWIRE FOR THE FEMORAL VENOUS CANNULA WAS ADVANCED UNDER FLUOROSCOPIC AND ECHOCARDIOGRAPHIC GUIDANCE. THE VENOUS DRAINAGE CANNULA WAS ADVANCED. A RIGHT VENTRICLE PERFORATION CONTAINING THE TIP OF THE VENOUS DRAINAGE CANNULA WAS NOTED BY THE SURGEON. AN UNEVENTFUL REPAIR WAS PERFORMED, AND THE OPERATION WAS COMPLETED WITHOUT INCIDENT. THE EPISODE WAS OF NO APPARENT CLINICAL CONSEQUENCE PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL VENOUS DRAINAGE CANNULA CANNULA DWF DLP, INC. EVDC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention